DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
FDA device recall Z-2148-2014 · posted 2014-08-20 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- Reason for recall
- DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively.
- Action taken
- The firm, DePuy Synthes, sent "Urgent Notice: Medical Device Recall" letters dated April 16, 2014 to affected customers. The letter identified the affected product, reason for recall, potential patient impact, mitigation steps for patients with distractors currently implanted and actions to be taken. Customers were instructed to review inventory, immediately remove the affected lots from stock, complete verification section of the letter and return the affected product. For questions call 610-719-5450 or contact your DePuy Synthes Sales consultant.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MQN
- Quantity affected
- 1499
- Distribution
- US Nationwide Distribution
- Date initiated
- 2014-04-16
- Date posted
- 2014-08-20
- Date terminated
- 2015-09-09
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM (K060138) | Synthes (Usa) | 2006-06-02 |