Recall Z-0404-2014 ยท JDS Nail, Fixation, Bone
Synthes (USA) Products LLC
Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic fractures, and tibial malunions and non-unions.
| Date | Nov 26, 2013 (initiated Oct 14, 2013) |
| Status | Terminated |
| Reason | Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar. |
| Root cause | Labeling mix-ups |
| Action | Synthes sent an Urgent Notice: Medical Device Recall letter dated October 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affected product to obtain a Return Authorization Number, complete the Verification Section at the end of the letter and return the Verification Form with the affected product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 If customers do not have the affected product they should complete t |
| Quantity | 55 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111667 | SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS Synthes (Usa), Dec 5, 2011 |