Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-
FDA device recall Z-2087-2013 · posted 2013-08-26 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with "R" for right plate when they should be etched with "L" for left plate.
- Action taken
- Synthes GMBH 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 and immediately remove the affected product from stock. Customers were advised to complete the Verification Section at the end of the letter. For questions call 610-719-5450 or contact your Synthes Sales Consultant.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 11
- Distribution
- USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN.
- Date initiated
- 2013-07-30
- Date posted
- 2013-08-26
- Date terminated
- 2015-05-21
- 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 (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES (K083694) | Synthes (Usa) | 2009-03-06 |