Recall Z-2389-2016 ยท HRS Plate, Fixation, Bone
Synthes (USA) Products LLC
Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices The 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm is a part of the following systems: - 2.4. mm Titanium LCP Distal Radius Plate System - Titanium LCP Compact Distal Radius Sys
| Date | Aug 11, 2016 (initiated Jun 28, 2016) |
| Status | Terminated |
| Reason | It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature leaving a thin wall between neck and drive. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated July 14, 2016 to affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately remove and return all unpackaged Locking Screws Self-Tapping with Stardrive Recess 12mm in any affected kits along with any screws still in the original packaging with the part number and lot number identified in the recall notification. Customers were also instructed to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorizati |
| Quantity | 41 units |
| Distribution | US Distribution to states of: AR, CA, CO, DE, FL, GA, IA, IL, KY, LA, MN, NJ, OK, PA, SD, TN, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012114 | SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM Synthes (Usa), Sep 28, 2001 |
| K050110 | SYNTHES (USA) LCP MODULAR FOOT PLATES Synthes (Usa), Mar 4, 2005 |
| K063049 | SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM Synthes (Usa), Dec 18, 2006 |
| K102694 | 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES Synthes (Usa), Dec 9, 2010 |
| K103243 | 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM Synthes (Usa), Jan 21, 2011 |