FDA Medical Device Recalls (openFDA)
Wright Medical Technology Inc: 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.
- Recall number
- Z-1637-2010
- Recalling firm
- Wright Medical Technology Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2009-11-24
- Posted
- 2010-05-21
- Terminated
- 2010-10-21
- Reason
- The left medial pivot and right medial pivot inserts were co-mingled
- Root cause
- Packaging process control
- Action
- 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.
- Quantity
- 47 units
- Distribution
- Worldwide Distribution -- United States, The Netherlands, Italy, Republic of Korea and Japan.
- Lot, serial or model codes
- Lot Number: 681644
- 510(k) numbers
- ["K972770"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1043534
- Firm city
- Arlington
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28