5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod
FDA device recall Z-1935-2013 · posted 2013-08-09 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. This product was produced using a finishing process not identified as part of the manufacturing specification. No adverse event reports associated with the use of this product were received, and an extensive engineering and medical safety review concluded that the product poses no incremental risk to t
- Action taken
- On June 5, 2013, De Puy Synthes notified by letter the direct acc acccounts which were identified to have received 5.0mm stainless steel rods and requested return of the product by calling 1-800-479-6329 to obtain a return authorization number. Completion of the verification section of the letter, including negative responses was also requested.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 492
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-06-05
- Date posted
- 2013-08-09
- Date terminated
- 2015-09-21
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES DUAL-OPENING USS (K020517) | Synthes (Usa) | 2002-04-15 |