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Waldemar Link GmbH & Co. KG (Mfg Site)
Waldemar Link GmbH & Co. KG (Mfg Site): 64 FDA recall reports
Every medical device recall the FDA has published for Waldemar Link GmbH & Co. KG (Mfg Site). The fault, and how the agency graded it.
64Reports
0Class I
61Ongoing
2026-04-01Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Z-1651-2026 · Class II · reported 2026-04-01 · Ongoing
- Why it was recalled
- The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
- Product
- Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
- Where it went
- US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
- How much
- 75 units
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Z-1652-2026 · Class II · reported 2026-04-01 · Ongoing
- Why it was recalled
- The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
- Product
- Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
- Where it went
- US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
- How much
- 74 units
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Z-1521-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Product
- Endo-Model Replacement Plateau; Item Number: 15-0027/11;
- Where it went
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
- How much
- 2 units (OUS only)
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Z-1517-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Product
- Endo-Model Replacement Plateau; Item Number: 15-8030/12;
- Where it went
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
- How much
- 4 units (all OUS)
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Z-1511-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Product
- Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
- Where it went
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
- How much
- 44 units (1 US, 43 OUS)
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Z-1520-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Product
- Endo-Model Replacement Plateau; Item Number: 15-8521/15;
- Where it went
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
- How much
- 4 units (OUS only)
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
Z-1512-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Product
- Endo-Model Replacement Plateau; Item Number: 15-0027/15;
- Where it went
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
- How much
- 3 units
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
Z-1515-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Product
- Endo-Model Replacement Plateau; Item Number: 15-2835/12;
- Where it went
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
- How much
- 1 unit (OUS only)
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Z-1514-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Product
- Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
- Where it went
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
- How much
- 31 units (OUS only)
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
Z-1516-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Product
- Endo-Model Replacement Plateau; Item Number: 15-2836/11;
- Where it went
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
- How much
- 7 units (OUS only)
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Z-1513-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Product
- Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
- Where it went
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
- How much
- 49 units (OUS only)
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Z-1518-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Product
- Endo-Model Replacement Plateau; Item Number: 15-8521/09;
- Where it went
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
- How much
- 8 units (OUS only)
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
Z-1519-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Product
- Endo-Model Replacement Plateau; Item Number: 15-8521/11;
- Where it went
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
- How much
- 7 units (OUS only)
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
Z-1522-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Product
- Endo-Model Replacement Plateau; Item Number: 15-0027/12;
- Where it went
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
- How much
- 1 unit (OUS only)
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Z-1523-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Product
- Endo-Model Replacement Plateau; Item Number: 15-0027/16;
- Where it went
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
- How much
- 3 units (OUS only)
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12.
Z-0890-2026 · Class II · reported 2025-12-17 · Ongoing
- Why it was recalled
- The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
- Product
- Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
- Where it went
- US distribution to states of: AL, GA, and TX.
- How much
- 18 units
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number
Z-2541-2025 · Class II · reported 2025-09-17 · Ongoing
- Why it was recalled
- Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
- Product
- LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
- Where it went
- Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.
- How much
- 8 units
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Z-2288-2025 · Class II · reported 2025-08-20 · Ongoing
- Why it was recalled
- Inconsistent size terminology and color coding used on labeling
- Product
- Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
- Where it went
- Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS, LA, NJ and the countries of Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hungary, Mexico, Netherlands, Peru, Slovenia, and Uruguay.
- How much
- 46 units
Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Z-2289-2025 · Class II · reported 2025-08-20 · Ongoing
- Why it was recalled
- Inconsistent size terminology and color coding used on labeling
- Product
- Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
- Where it went
- Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS, LA, NJ and the countries of Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hungary, Mexico, Netherlands, Peru, Slovenia, and Uruguay.
- How much
- 17 units
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemente
Z-1700-2025 · Class II · reported 2025-05-07 · Ongoing
- Why it was recalled
- The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Product
- Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7) 880-313/21 (Sz. 3-4 - cemented lg), (8) 880-313/22 (Sz. 3-4 - cemented x-lg), (9) 880-315/11 (Sz. 5-6 - cemented sm), (10) 880-315/12 (Sz. 5-6 - cemented md), (11) 880-315/21 (Sz. 5-6 - cemented lg), (12) 880-315/22 (Sz. 5-6 - cemented x-lg), (13) 880-317/11 (Sz. 7-8 - cemented sm), (14) 880-317/12 (Sz. 7-8 - cemented md), (15) 880-317/21 (Sz. 7-8 - cemented lg), (16) 880-317/22 (Sz. 7-8 - cemented x-lg), (17) 880-319/11 (Sz. 9-10 - cemented sm), (18) 880-319/12 (Sz. 9-10 - cemented md), (19) 880-319/21 (Sz. 9-10 - cemented lg), (20) 880-319/22 (Sz. 9-10 - cemented x-lg).
- Where it went
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, WI.
- How much
- 908 units
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm)
Z-1702-2025 · Class II · reported 2025-05-07 · Ongoing
- Why it was recalled
- The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Product
- Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7) 880-333/11 (Sz. 3-4 - cemented x-sm), (8) 880-333/12 (Sz. 3-4 - cemented sm), (9) 880-333/13 (Sz. 3-4 - cemented md), (10) 880-333/21 (Sz. 3-4 - cemented lg), (11) 880-333/22 (Sz. 3-4 - cemented x-lg), (12) 880-333/23 (Sz. 3-4 - cemented xx-lg), (13) 880-335/11 (Sz. 5-6 - cemented x-sm), (14) 880-335/12 (Sz. 5-6 - cemented sm), (15) 880-335/13 (Sz. 5-6 - cemented md), (16) 880-335/21 (Sz. 5-6 - cemented lg), (17) 880-335/22 (Sz. 5-6 - cemented lg), (18) 880-335/23 (Sz. 5-6 - cemented xx-lg), (19) 880-337/11 (Sz. 7-8 - cemented x-sm), (20) 880-337/12 (Sz. 5-6 - cemented sm), (21) 880-337/13 (Sz. 7-8 - cemented md), (22) 880-337/21 (Sz. 7-8 - cemented lg), (23) 880-337/22 (Sz. 7-8 - cemented x-lg), (24) 880-337/23 (Sz. 7-8 - cemented xx-lg), (25) 880-339/11 (Sz. 9-10 - cemented x-sm), (26) 880-339/12 (Sz. 9-10 - cemented sm), (27) 880-339/13 (Sz. 9-10 - cemented md), (28) 880-339/21 (Sz. 9-10 - cemented...
- Where it went
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, WI.
- How much
- 1771 units
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented l
Z-1699-2025 · Class II · reported 2025-05-07 · Ongoing
- Why it was recalled
- The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Product
- Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 880-303/21 (Sz. 3-4 - cemented lg), (8) 880-303/22 (Sz. 3-4 - cemented x-lg), (9) 880-305/11 (Sz. 5-6 - cemented sm), (10) 880-305/12 (Sz. 5-6 - cemented md), (11) 880-305/21 (Sz. 5-6 - cemented lg), (12) 880-305/22 (Sz. 5-6 - cemented x-lg), (13) 880-307/11 (Sz. 7-8 - cemented sm), (14) 880-307/12 (Sz. 7-8 - cemented md), (15) 880-307/21 (Sz. 7-8 - cemented lg), (16) 880-307/22 (Sz. 7-8 - cemented x-lg), (17) 880-309/11 (Sz. 9-10 - cemented sm), (18) 880-309/12 (Sz. 9-10 - cemented md), (19) 880-309/21 (Sz. 9-10 - cemented lg), (20) 880-309/22 (Sz. 9-10 - cemented x-lg).
- Where it went
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, WI.
- How much
- 1180 units
L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented
Z-1701-2025 · Class II · reported 2025-05-07 · Ongoing
- Why it was recalled
- The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Product
- L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7) 880-325/13 (Sz. 5-6 - cemented sm), (8) 880-325/23 (Sz. 5-6 - cemented lg), (9) 880-327/13 (Sz. 7-8 - cemented sm), (10) 880-327/23 (Sz. 7-8 - cemented lg), (11) 880-329/13 (Sz. 9-10 - cemented sm), (12) 880-329/23 (Sz. 9-10 - cemented lg).
- Where it went
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, WI.
- How much
- 441 units
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
Z-1372-2025 · Class II · reported 2025-03-26 · Ongoing
- Why it was recalled
- A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
- Product
- Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
- Where it went
- Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.
- How much
- 37 units
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
Z-1374-2025 · Class II · reported 2025-03-26 · Ongoing
- Why it was recalled
- A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
- Product
- Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
- Where it went
- Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.
- How much
- 20 units
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
Z-1373-2025 · Class II · reported 2025-03-26 · Ongoing
- Why it was recalled
- A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
- Product
- Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
- Where it went
- Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.
- How much
- 52 units
LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offs
Z-0769-2025 · Class II · reported 2025-01-01 · Ongoing
- Why it was recalled
- Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
- Product
- LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.
- Where it went
- US Nationwide distribution in the states of AL, FL.
- How much
- 3 units
Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibi
Z-2411-2024 · Class II · reported 2024-07-24 · Ongoing
- Why it was recalled
- Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
- Product
- Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm
- Where it went
- Nationwide Foreign: Algeria Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada China Colombia Czechia Denmark Ecuador Estonia Finland France Germany Greece Hungary India Indonesia Israel Italy Kenya Lithuania Luxembourg Mexico Netherlands Norway Peru Poland Romania Saudi Arabia Slovakia Slovenia Spain Sweden Switzerland Thailand T¿rkiye Ukraine United Arab Emirates United Kingdom Uruguay Vietnam
- How much
- 114 units US; 2351 units OUS
Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/
Z-2410-2024 · Class II · reported 2024-07-24 · Ongoing
- Why it was recalled
- Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
- Product
- Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33
- Where it went
- Nationwide Foreign: Algeria Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada China Colombia Czechia Denmark Ecuador Estonia Finland France Germany Greece Hungary India Indonesia Israel Italy Kenya Lithuania Luxembourg Mexico Netherlands Norway Peru Poland Romania Saudi Arabia Slovakia Slovenia Spain Sweden Switzerland Thailand T¿rkiye Ukraine United Arab Emirates United Kingdom Uruguay Vietnam
- How much
- 552 units; 7351 units OUS
SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
Z-1299-2024 · Class II · reported 2024-03-20 · Ongoing
- Why it was recalled
- Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
- Product
- SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
- Where it went
- US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, NJ, NV, PA, TN, TX, VA, WA.
- How much
- 0 units
Showing the 30 most recent of 64. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls