Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small
FDA device recall Z-0406-2014 · posted 2013-11-27 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate.
- Action taken
- Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory, immediately remove the affected product and return to Credit/Returns, Synthes. For questions call 610-719-5450.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 13
- Distribution
- Worldwide Distribution - USA (nationwide) including IN, NY, WA, NE, MD, TX, AL, MI, and Internationally to Canada.
- Date initiated
- 2013-07-30
- Date posted
- 2013-11-27
- Date terminated
- 2015-08-17
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES MODULAR FOOT SYSTEM (K001941) | Synthes (Usa) | 2000-09-22 |