Encore Medical, Lp: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.

Agency Publication Date: January 10, 2018

Affected Products

Product: DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.

Lot 252567

Lot Numbers:

252567

Product: EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.

Lot 252564

Lot Numbers:

252564

Product: EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.

Lot 252564

Lot Numbers:

252564

Product: EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.

Lot 252564

Lot Numbers:

252564

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78727

Status: Resolved

Manufacturer: Encore Medical, Lp

Manufactured In: United States

Units Affected: 4 products (2 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.

Lot 252567

Lot Numbers:

252567

Product: EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.

Lot 252564

Lot Numbers:

252564

Product: EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.

Lot 252564

Lot Numbers:

252564

Product: EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.

Lot 252564

Lot Numbers:

252564