Encore Medical Recalls EMPOWR Locking Femoral Impactor Due to Tip Breakage
Encore Medical is recalling 410 EMPOWR Locking Femoral Impactors because the tips may break off during surgery. This defect can cause off-axis loading, device failure, and potential long-term complications.
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: The recall is classified as FDA Class II. The hazard involves a risk of harm (infection, pain, inflammatory response) from a device failure, but the source text does not report any confirmed illnesses or injuries, placing it in the 'High' category per the rubric.
Plain-English summary
Encore Medical, Lp is recalling 410 units of the EMPOWR Locking Femoral Impactor, Part # 800-05-035. These devices are packaged in the instrument tray FA EMP PAT TOOL KIT, Part # 800-99-096. The recall covers all lots of the product.
The recall was initiated after the firm received reports and complaints regarding the breakage of the tips on the locking femoral impactor. The company notes that if the impactor is not seated correctly on the implant prior to impaction, it may cause off-axis loading, which can increase the risk of device failure. This issue could result in a delay in surgery.
If a broken tip is not identified and removed during surgery, long-term risks may include an inflammatory response, infection, and/or pain. The affected devices were distributed to facilities in numerous states, including Colorado, Washington, California, Utah, Tennessee, Texas, Mississippi, Missouri, Arkansas, Oklahoma, Louisiana, Minnesota, Illinois, Indiana, Kentucky, Ohio, Michigan, Pennsylvania, South Carolina, Florida, Puerto Rico, Alabama, Georgia, New Mexico, Arizona, Nevada, Virginia, Rhode Island, Maryland, Maine, and New York.
The recalled product
- Product
- EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
- Manufacturer
- Encore Medical, Lp
- Affected units
- 410
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 (1)
- All Lots
Distribution
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