FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13
- Recall number
- Z-0522-2007
- Recalling firm
- Exactech, Inc.
- Product
- Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13
- Status
- Terminated
- Initiated
- 2006-12-07
- Posted
- 2007-02-27
- Terminated
- 2012-07-11
- Reason
- The outside profile on this manufactured lot of devices is oversized and does not meet specifications.
- Root cause
- Other
- Action
- Letter dated 12/08/06. The firm representative retrieved all four devices from the field.
- Quantity
- 4 units
- Distribution
- Distributed to one hospital in New York.
- Lot, serial or model codes
- serial numbers: 0900529-0900532
- 510(k) numbers
- ["K933494"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1038671
- Firm city
- Gainesville
- Firm state
- FL
- 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