Recall record at a glance
| Official record | Z-0479-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Encore Medical, LP |
| Report date | Dec 2, 2020 |
| Recall initiation date | Jun 19, 2020 |
| Quantity | 28 units |
| Location | Austin, TX, United States |
Official product description
EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
Why the product was recalled
There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.
Distribution information
US: AZ, CA, FL, GA, IL, IN, MI, MN, NY, TX, VA, and WA.. No OUS Consignees.
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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