Recall Z-2087-2013 ยท HRS Plate, Fixation, Bone
Synthes USA HQ, Inc.
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.
| Date | Aug 26, 2013 (initiated Jul 30, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 11 |
| Distribution | USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083694 | SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES Synthes (Usa), Mar 6, 2009 |