Device product
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.
Z-2131-2014
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 68657
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28 units
- Official record key
device-enforcement:Z-2131-2014
Official wording
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.
Code information: Part Number 00-2358-014-04; lot 62276042
Distribution pattern: Worldwide Distribution - US including the states of CA and OH., and the countries of BRAZIL, CHINA, KOREA and TAIWAN.
Derived failure modes
-
Unknown
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.