Agency classClass IIOur severity:High FDA (Devices)·Z-0060-2021·Announced 2020-10-14

DJO EMPOWR Tibial Knee Punch Handle Recall Due to Retaining Pin Risk

Encore Medical is recalling 190 units of DJO EMPOWR Tibial Knee Punch Handles because the retaining pin may fall out, potentially leaving debris in the joint space.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria for potential debris in the joint space.

Plain-English summary

Encore Medical, LP is recalling 190 units of the DJO EMPOWR Tibial Knee Punch Handle, Part No. 801-05-040 and 801-05-018. These instruments are used in conjunction with Tibial Punch Guides to broach the tibial canal in preparation for the tibial baseplate keel. The affected units are contained in the Instrument Tray for EMPOWR Porous Knee.

The recall is due to a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If this occurs and goes undetected, there is a potential for leaving debris in the joint space.

The affected products were distributed nationwide in the United States, including in the states of VA, TN, MN, TX, IL, IN, KY, OH, SC, RI, MD, PA, NY, CA, KS, OK, AR, LA, FL, AL, GA, AZ, NV, WA, MS, ME, and Puerto Rico. Specific lot and serial numbers are listed in the structured product information. Healthcare providers should stop using the affected handles and contact Encore Medical for instructions on return or replacement.

The recalled product

Product: DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately sized Tibial Punch Guides to broach the tibial canal in…
Manufacturer: Encore Medical, LP
Category: Medical Device — Surgical Instrument
Hazard: foreign-object
mechanical-failure
Affected units: 190

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

Model/Catalog no. 801-05-040
:Lot/serial No.s 281905L08
281905L15
283808L01
305197L02
318871L10 Model/Catalog no. 801-05-018
Lot/serial No.s: 215488L08
236760L01
228231L01
241946L02
259710L01
314969L01

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Same manufacturer · Encore Medical, LP

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