Recall Z-2601-2014
Wright Medical Technology, Inc. · initiated July 30, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Codes / lots: Lot Numbers: 1487673, 1487674, 1487675, 1487676, 1490003, 1512150, 1512151, 1519497, 1519498, 1522019, 1522020, 1523747, 1523748, 1537072, 1537073, 1537162, 1539399, 1541615, 1541616, 1543148, 1543149
Reason for recall
Plates manufactured from an incorrect raw material.
FDA-determined 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.
Details
- Recall number
- Z-2601-2014
- Initiated
- July 30, 2014
- Posted by FDA
- September 8, 2014
- Terminated
- June 15, 2018
- Product code
- HRS – Plate, Fixation, Bone
- Quantity
- 497 units
- Distribution
- Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.
- Recalling firm
- Wright Medical Technology, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2599-2014 Class II | CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-2600-2014 Class II | CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-2602-2014 Class II | CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-2603-2014 Class II | CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-2604-2014 Class II | CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-2605-2014 Class II | CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-2607-2014 Class II | CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-2608-2014 Class II | CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |