EMPOWR Locking Femoral Impactor — Class II medical device recall Z-0611-2020
Ongoing recall by Encore Medical, Lp, reported 2019-12-18, distributed in AL, AR, AZ, CA, CO, FL, GA, IL…. The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor.
| Recall number | Z-0611-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2019-02-04 |
| Classified | 2019-12-06 |
| Reported by FDA | 2019-12-18 |
| Distributed | AL, AR, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MD, ME, MI, MN, MO, MS, NM, NV, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA, WA |
| Quantity | 410 devices |
| Reason classes | device malfunction |
| Model numbers | 800-05-035, 800-99-096 |
Product
EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
Reason for recall
The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which can increase the risk of device failure. This could cause a delay in surgery. If the tip is not seen during surgery, long term risks may include an inflammatory response, infection, and/ or pain
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0611-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.