Recall Z-2131-2014 ยท HRS Plate, Fixation, Bone
Zimmer, Inc.
Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.
| Date | Jul 30, 2014 (initiated Jun 10, 2014) |
| Status | Terminated |
| Reason | A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted in the screw head pulling through plate hole. |
| Root cause | Device Design |
| Action | Zimmer sent an Urgent Medical Device Recall letter dated June 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. They instructed their distributors to do the following: 1. Please locate, quarantine, and return the affected product (part number 00-2358-014-04; lot 62276042) from all inventories. 2. Please note that any hospitals that received direct shipments of this product from Zimmer will be sent a copy of the Risk Manager and Surgeon letter directly. Additionally, Risk Managers and Surgeon that were iden |
| Quantity | 28 units |
| Distribution | Worldwide Distribution - US including the states of CA and OH., and the countries of BRAZIL, CHINA, KOREA and TAIWAN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040593 | PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES Zimmer, Inc., Apr 12, 2004 |