Recall record at a glance
| Official record | Z-0060-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Encore Medical, LP |
| Report date | Oct 14, 2020 |
| Recall initiation date | Aug 3, 2020 |
| Quantity | 190 units |
| Location | Austin, TX, United States |
Official product description
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 preparation for the tibial baseplate keel.
Why the product was recalled
There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.
Distribution information
U.S. Nationwide distribution 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, NV and Puerto Rico.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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