Exactech, Inc. Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13
Brand
Exactech, Inc.
Lot Codes / Batch Numbers
serial numbers: 0900529-0900532
Products Sold
serial numbers: 0900529-0900532
Exactech, Inc. is recalling Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee pro due to The outside profile on this manufactured lot of devices is oversized and does not meet specifications.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The outside profile on this manufactured lot of devices is oversized and does not meet specifications.
Recommended Action
Per FDA guidance
Letter dated 12/08/06. The firm representative retrieved all four devices from the field.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, NY
Page updated: Jan 10, 2026