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Terminated

Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13

FDA Recall Z-0522-2007 · Posted 2007-02-27

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2006-12-07
Date Terminated2012-07-11
Product Quantity4 units

Reason for Recall

The outside profile on this manufactured lot of devices is oversized and does not meet specifications.

Firm Action

Letter dated 12/08/06. The firm representative retrieved all four devices from the field.

Root Cause

Other

Distribution Pattern

Distributed to one hospital in New York.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K933494EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEMExactech, Inc. · 1995-03-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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