FDA Enforcement
Class II
Terminated
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.
Recall: Z-2131-2014
·
Reported August 6, 2014
Enforcement
- Recall Number
- Z-2131-2014
- Event ID
- 68657
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zimmer, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- August 6, 2014
- Initiation Date
- June 10, 2014
- Classification Date
- July 30, 2014
- Termination Date
- January 9, 2015
- Address
- 1800 W Center St, Warsaw, IN, 46580-2304, United States
Description
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.
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 Info
Part Number 00-2358-014-04; lot 62276042
Distribution
Worldwide Distribution - US including the states of CA and OH., and the countries of BRAZIL, CHINA, KOREA and TAIWAN.
Quantity
28 units