Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengt
FDA device recall Z-0904-2013 · posted 2013-03-01 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
- Action taken
- The firm, Synthes (USA) sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firmat 610-719-5450 for questions regarding this notice.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DZL
- Quantity affected
- 24
- Distribution
- Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.
- Date initiated
- 2013-01-11
- Date posted
- 2013-03-01
- Date terminated
- 2015-08-31
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR (K010690) | Synthes (Usa) | 2001-05-18 |