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Terminated

Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.

FDA Recall Z-0158-2018 · Posted None

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2017-09-19
Date Terminated2021-06-21
Product Quantity411 devices

Reason for Recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Firm Action

The recalling firm issued a letter dated 9/19/2017 via email to their customers.

Root Cause

Labeling design

Distribution Pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023186OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAYExactech, Inc. · 2002-10-17

Official Source

View FDA Recall →

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

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