| Class 2 Device Recall Stryker | |
Date Initiated by Firm | December 01, 2023 |
Date Posted | January 31, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0899-2024 |
Recall Event ID |
93687 |
510(K)Number | K030978 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product | Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement
Part Number: 82-2-0908 |
Code Information |
GTIN: 04546540400734
Lot Numbers: 42874701, 42912101, 42995601
|
Recalling Firm/ Manufacturer |
Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2006
|
For Additional Information Contact | Loriann Russo 201-831-5000 |
Manufacturer 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. |
FDA Determined Cause 2 | Nonconforming Material/Component |
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
strykerortho4367@sedgwick.com
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
SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = JWH
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