The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System
FDA device recall Z-1127-2013 · posted 2013-04-17 · Terminated
Recall details
- Recalling firm
- Synvasive Technology Inc
- Reason for recall
- Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
- Action taken
- An Urgent Medical Device Recall Notice letter dated March 21, 2013 was sent to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use; remove the products from inventory and complete and return the attached Response Form. For questions call 574-372-1570.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- HSD
- Quantity affected
- 100 kits
- Distribution
- USA Nationwide Distributor including the state of IN
- Date initiated
- 2013-03-14
- Date posted
- 2013-04-17
- Date terminated
- 2014-01-13
- Location
- El Dorado Hills, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TEMPERLITE(TM) SAW BLADE (K911902) | Sierra Surgical, Inc. | 1991-06-28 |