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
FDA device recall Z-0134-2016 · posted 2015-10-17 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- This product was produced using a finishing process not identified as part of the manufacturing specification. The process used with the lots subject to this Recall was a bead blast process. (Bead Blasting vs. Shot Peened).
- Action taken
- An Urgent Notice: Medical Device Recall, dated September 4, 2015, was sent to end users to alert them about the issue and possible risk to patients. Customers were requested to follow the actions to be taken for if they have affected product or not; complete the response form, and return affected product. Customers can call 610-719-5450 or a local Synthes Sales Consultant with any questions.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 492
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-09-04
- Date posted
- 2015-10-17
- Date terminated
- 2016-08-26
- 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 |