Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio P
FDA device recall Z-2789-2016 · posted 2016-09-13 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument.
- Action taken
- Stryker sent an "Urgent Medical Device Recall Notification" Letter and Recall Business Reply Form dated August 1, 2016 to their affected customers via email and also via UPS on August 1, 2016. Customers are asked to quarantine the product subject to this recall. Branches/Agencies are asked to return all affected products available at their location to: Stryker C/O Stericycle, Attn: RA 2016-098 - Event 8296. Hospital/Branches: Customers are asked to complete and sign the Business Reply Form and fax a copy within 5 business days to: 877-272-6141 or email to Stericycle strykerortho8296@stericycle.com. Any questions, customers can call (201) 831-6693.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MBH
- Quantity affected
- 2,039 units
- Distribution
- US Nationwide and Internationally
- Date initiated
- 2016-08-01
- Date posted
- 2016-09-13
- Date terminated
- 2017-06-08
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCORPIO TOTAL KNEE SYSTEM (K033972) | Howmedica Osteonics Corp. | 2004-04-12 |