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Empowr PS Knee Tibial Insert recallZ-1139-2017 · Encore Medical, Lp · initiated Jan 10, 2017

Class II Terminated All recalls posted in February 2017

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 Empowr PS Insert was reported as missing the impaction slot feature.

FDA root cause category: Component design/selection

What the company is doing

DJO Global sent an Urgent Field Safety Notice dated January 10, 2017, to all affected customers. The Field Safety Notice instructs the agents to notify all individuals within their organization or to any organization where the potentially affected product has been transferred. Customers with questions should contact customer service at 1-800-456-8696. For questions regarding this recall call 512-832-9500.

Recall details

Recall number
Z-1139-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 10, 2017
Posted by the FDA
Feb 3, 2017
Recalling firm
Encore Medical, Lp
Quantity
24 units
Product code
JWH
FDA submissions
K160342
Distribution
Nationwide Distribution to CO, NY, and FL

Product description

Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.

Code information (models, lots, serial numbers)

035U1000

Other devices under the same FDA submission

80 devices cleared under K160342 — 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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