Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STE
FDA device recall Z-0401-2014 · posted 2013-11-26 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- A plate was inadvertently released to a sales consultant that was restricted for sale.
- Action taken
- Synthes sent a letter dated November 7, 2013, to the implanting surgeon to follow up on a complaint received. The firm requested any additional information the surgeon might have about the use of the plate as well as a status on the patient following use. For questions the surgeon was instructed to call 800-620-7025. For questions regarding this recall call 610-719-5000.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JDP
- Quantity affected
- 1
- Distribution
- US Distribution in Colorado.
- Date initiated
- 2013-05-29
- Date posted
- 2013-11-26
- Date terminated
- 2015-05-21
- Location
- West Chester, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM (K110354) | Synthes USA | 2011-03-04 |