SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
FDA device recall Z-0893-2024 · posted 2024-01-31 · Open, Classified
Recall details
- Recalling firm
- Howmedica Osteonics Corp.
- 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.
- Action taken
- 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
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 107 units US; 176 units OUS
- Distribution
- Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated
- Date initiated
- 2023-12-01
- Date posted
- 2024-01-31
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER COMPARTMENTAL KNEE SYSTEM (K052917) | Howmedica Osteonics Corp. | 2005-12-27 |
| AVON PATELLO-FEMORAL JOINT PROSTHESIS (K051948) | Howmedica Osteonics Corp. | 2005-10-21 |
| OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT (K972967) | Osteonics Corp. | 1998-01-16 |