Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.
- Company
- Synthes Usa (Hq), Inc.
- Recall Initiated
- July 30, 2013
- Posted
- August 26, 2013
- Terminated
- May 21, 2015
- Recall Number
- Z-2087-2013
- Quantity
- 11
- Firm Location
- West Chester, PA
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.
Distribution
USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN.
Lot / Code Info
Part No. 02.111.730, with Lot No. 3614792
Root Cause
Process control
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.