CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE Orthopedic
- Company
- Wright Medical Technology, Inc.
- Recall Initiated
- July 30, 2014
- Posted
- September 8, 2014
- Terminated
- June 15, 2018
- Recall Number
- Z-2604-2014
- Quantity
- 178 units
- Firm Location
- Memphis, TN
Reason for Recall
Plates manufactured from an incorrect raw material.
Distribution
Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.
Lot / Code Info
Lot Numbers: 1487670, 1487671, 1487672, 1512149, 1519496, 1523745, 1534796, 1537159, 1539400, 1540714
Root Cause
Device Design
Action Taken
Wright Medical sent an Urgent Medical Device Recall letter dated July 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product and immediately quarantine all affected product and return to Wright Medical as soon as possible. For return instructions customers were instructed to contact Customer Service at 800-238-7117. Customers were also asked to complete the attached response form, confirming receipt of the notice and the status of the product(s) on hand and return by fax to 901-867-7401. Customers with questions were instructed to call 901-290-5662. For questions regarding this recall call 800-238-7117.