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Terminated

Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.

FDA Recall Z-0165-2016 · Posted 2015-10-26

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeOIY
Date Initiated2015-09-16
Date Terminated2016-01-04
Product Quantity209 units

Reason for Recall

The labeling is missing the size/diameter information.

Firm Action

DJO Surgical sent an Urgent Field Safety Notice dated September 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter requested the consignees complete and return a response card and return affected devices for replacement. For further questions call (512) 832-6302.

Root Cause

Labeling design

Distribution Pattern

US Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO.

Official Source

View FDA Recall →

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

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