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Howmedica Osteonics Corp.
Howmedica Osteonics Corp.: 232 FDA recall reports
Every medical device recall the FDA has published for Howmedica Osteonics Corp.. The fault, and how the agency graded it.
232Reports
0Class I
110Ongoing
2026-06-24Most 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.
TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
Z-2461-2026 · Class II · reported 2026-06-24 · Ongoing
- Why it was recalled
- Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
- Product
- TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
- Where it went
- US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.
- How much
- 7 units
TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
Z-2462-2026 · Class II · reported 2026-06-24 · Ongoing
- Why it was recalled
- Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
- Product
- TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
- Where it went
- US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.
- How much
- 7 units
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
Z-1572-2026 · Class II · reported 2026-03-25 · Ongoing
- Why it was recalled
- A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.
- Product
- MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
- Where it went
- Domestic: Nationwide Distribution; International: Australia, Germany, Belgium, France, Spain UK, New Zealand;
- How much
- 1098 units
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) wi
Z-0963-2026 · Class II · reported 2025-12-31 · Ongoing
- Why it was recalled
- When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
- Product
- The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.
- How much
- 320 units
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog
Z-2640-2025 · Class II · reported 2025-10-08 · Ongoing
- Why it was recalled
- a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
- Product
- 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
- Where it went
- International distribution in the country of United Kingdom.
- How much
- 55 units (all OUS)
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Z-0044-2025 · Class II · reported 2024-10-16 · Ongoing
- Why it was recalled
- Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
- Product
- MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Germany.
- How much
- 897 units
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applic
Z-0023-2025 · Class II · reported 2024-10-16 · Ongoing
- Why it was recalled
- Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
- Product
- Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200
- Where it went
- US Nationwide distribution in the states of AZ, FL, NC, OH, PA, TN, WI. Stryker issued Urgent Medical Device Recall (UMDR) PFA 3554908 by third party Sedgwick on September 04, 2024, via UPS 2-day air. Letter states reason for recall, health risk and action to take: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list (Table 1). 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form: " Medical Facility: Please sign the Business Reply Form and email to: [email protected]/ Fax: (800) 871-7417 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices to Stryker using the following...
- How much
- 16 units
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Numbe
Z-2732-2024 · Class II · reported 2024-09-04 · Ongoing
- Why it was recalled
- A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
- Product
- Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
- Where it went
- International distribution to the country of Australia.
- How much
- 1 unit (OUS only)
UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalo
Z-2370-2024 · Class II · reported 2024-07-24 · Ongoing
- Why it was recalled
- Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
- Product
- UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.
- How much
- 18 units
UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalo
Z-2372-2024 · Class II · reported 2024-07-24 · Ongoing
- Why it was recalled
- Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
- Product
- UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.
- How much
- 12 units
UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalo
Z-2371-2024 · Class II · reported 2024-07-24 · Ongoing
- Why it was recalled
- Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
- Product
- UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.
- How much
- 18 units
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Z-2153-2024 · Class II · reported 2024-06-26 · Ongoing
- Why it was recalled
- The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
- Product
- Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
- Where it went
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, Denmark, Hong Kong, Iran, Italy, Japan, Kuwait, Mexico, New Zealand, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, UK, Venlo.
- How much
- 209 units
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Z-2152-2024 · Class II · reported 2024-06-26 · Ongoing
- Why it was recalled
- The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
- Product
- HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
- Where it went
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, Denmark, Hong Kong, Iran, Italy, Japan, Kuwait, Mexico, New Zealand, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, UK, Venlo.
- How much
- 630 units
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation
Z-1631-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Product
- TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
- Where it went
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- How much
- 0
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation
Z-1628-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Product
- TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
- Where it went
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- How much
- 0
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation
Z-1627-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Product
- TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
- Where it went
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- How much
- 0
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation
Z-1622-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Product
- TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
- Where it went
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- How much
- 45 units
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation
Z-1630-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Product
- TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
- Where it went
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- How much
- 3 units
TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation
Z-1632-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Product
- TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H
- Where it went
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- How much
- 0
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation
Z-1623-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Product
- TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
- Where it went
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- How much
- 0
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation
Z-1624-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Product
- TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
- Where it went
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- How much
- 48 units
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation
Z-1626-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Product
- TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
- Where it went
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- How much
- 0
TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation
Z-1629-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Product
- TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D
- Where it went
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- How much
- 0
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation
Z-1621-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Product
- TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B
- Where it went
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- How much
- 0
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation
Z-1625-2024 · Class II · reported 2024-05-01 · Ongoing
- Why it was recalled
- The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
- Product
- TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
- Where it went
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- How much
- 225 units
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Z-1264-2024 · Class II · reported 2024-03-13 · Ongoing
- Why it was recalled
- Potential packaging breaches of inner blister and outer sterile blister.
- Product
- NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
- Where it went
- Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
- How much
- 18 units (US); 5 units (OUS)
X3 TRIATHLON CS INSERT NO 6 10 MM
Z-1260-2024 · Class II · reported 2024-03-13 · Ongoing
- Why it was recalled
- Potential packaging breaches of inner blister and outer sterile blister.
- Product
- X3 TRIATHLON CS INSERT NO 6 10 MM
- Where it went
- Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
- How much
- 143 units (US)
X3 TRIATHLON CS INSERT NO 3 10 MM
Z-1259-2024 · Class II · reported 2024-03-13 · Ongoing
- Why it was recalled
- Potential packaging breaches of inner blister and outer sterile blister.
- Product
- X3 TRIATHLON CS INSERT NO 3 10 MM
- Where it went
- Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
- How much
- 132 units (US); 26 units (OUS)
NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Z-1263-2024 · Class II · reported 2024-03-13 · Ongoing
- Why it was recalled
- Potential packaging breaches of inner blister and outer sterile blister.
- Product
- NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
- Where it went
- Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
- How much
- 39 units (US); 10 units (OUS)
X3 TRIATHLON CS INSERT NO 7 9 MM
Z-1262-2024 · Class II · reported 2024-03-13 · Ongoing
- Why it was recalled
- Potential packaging breaches of inner blister and outer sterile blister.
- Product
- X3 TRIATHLON CS INSERT NO 7 9 MM
- Where it went
- Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
- How much
- 24 units (US)
Showing the 30 most recent of 232. 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