Recall StatusOpen, Classified
Date Initiated2023-12-01
Product Quantity36 units US
Reason for Recall
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Firm Action
Stryker issued Urgent Medical Device Recall Letter (Product Field Action #: 3306872)through third party Sedgwick via UPS on 12/1/23. Letter states reason for recall, health risk and action to take:
Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who
need to be made aware.
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 affected product in Part/Lot Number Attachment: PFA 3306872
starting on page 3.
4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to
[email protected]
5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions.
6. Please return ALL affected product to:
Stryker Orthopaedics/PFA Product Returns
Attn: Distribution Inventory Team
325 Corporate Drive
Dock M-East
Mahwah, NJ 07430
Ref. PFA 3306872; Please include Tracking information on the package.
If you have any questions or concerns after reviewing
this letter, please contact Customer Service at (201) 831-5000. For questions pertaining to the recall, email
[email protected]
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide
Foreign:
Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands).
***Updated 1/25/24***
Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.