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Exprt Precision System: Revision Knee, Model Number… recallZ-0165-2016 · Encore Medical, Lp · initiated Sep 16, 2015

Class II Terminated All recalls posted in October 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Encore Medical, Lp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The labeling is missing the size/diameter information.

FDA root cause category: Labeling design

What the company is doing

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.

Recall details

Recall number
Z-0165-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 16, 2015
Posted by the FDA
Oct 26, 2015
Recalling firm
Encore Medical, Lp
Quantity
209 units
Product code
OIY
FDA submissions
K140830
Distribution
US Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO.

Product description

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.

Code information (models, lots, serial numbers)

471T1-001/011; 472T1-000/014; 473T1-000/015; 474T1-000/010; 475T1-000/008

Other devices under the same FDA submission

27 devices cleared under K140830 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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