Recalls / —
—#129462
Product
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic
- FDA product code
- HRS — Plate, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K080295, K113014, K133715
- Affected lot / code info
- Lot Numbers: 1490004, 1490005, 1490199, 1490200, 1490201, 1490202, 1518483, 1519493, 1519494, 1519495, 1522021, 1522898, 1522899, 1522900, 1523735, 1523736, 1526519, 1526520, 1526521, 1538760, 1538761, 1539402, 1540715, 1540716, 1540717, 1542703, 1542704, 1542776, 1543491, 1543891
Why it was recalled
Plates manufactured from an incorrect raw material.
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Wright Medical Technology, Inc.
- Address
- 1023 Cherry Rd, Memphis, Tennessee 38117-5423
Distribution
- Distribution pattern
- Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.
Timeline
- Recall initiated
- 2014-07-30
- Posted by FDA
- 2014-09-08
- Terminated
- 2018-06-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #129462. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.