ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients.
This recall has been terminated (originally issued May 21, 2010).
- Company
- Wright Medical Technology Inc
- Recall Initiated
- November 24, 2009
- Posted
- May 21, 2010
- Terminated
- October 21, 2010
- Recall Number
- Z-1637-2010
- Quantity
- 47 units
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
Reason for Recall
The left medial pivot and right medial pivot inserts were co-mingled
Distribution
Worldwide Distribution -- United States, The Netherlands, Italy, Republic of Korea and Japan.
Lot / Code Info
Lot Number: 681644
Root Cause
Packaging process control
Action Taken
Wright Medical Technology, Inc. issued an "Urgent: Medical Device Voluntary Recall" notification dated November 24, 2009. The letters were addressed to distributors, hospital administrators, and surgeons. Consignees were asked to return all affected product in addition to a completed Response Form to the firm. For further information, contact Wright Medical Technology, Inc. at 1-800-874-5630.
More recalls by Wright Medical Technology Inc
EVOLVE STEM 8.5MM
Model # 496S085
Aug 26, 2020