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.
What this means for you
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 prep
- Manufacturer
- Encore Medical, LP
- 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
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