Encore Medical Recalls EMPOWR Acetabular Impactor Balls Due to Fracturing
Encore Medical is recalling 86 units of EMPOWR Acetabular Impactor Balls because they may fracture during use, potentially leaving debris in the joint space.
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 (debris in the joint space) from a medical device defect, but the source text does not report specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Encore Medical, LP is recalling 86 units of the EMPOWR Acetabular System, Non-Sterile, specifically the Impactor Balls. The affected model numbers are 803-15-023, 803-15-026, 803-15-027, 803-15-028, 803-15-029, and 803-15-030. The recall covers all lots of these specific models.
The recall was initiated after the firm received complaints that the impactor balls were fracturing or cracking during the impaction process. This defect could cause debris to migrate or be left in the joint space of the patient. The product is intended for use in joint replacement surgeries for patients with conditions such as osteoarthritis, avascular necrosis, rheumatoid arthritis, or femoral fractures.
The affected units were distributed nationwide in the United States, including in the states of Minnesota, Virginia, Illinois, Indiana, South Carolina, North Carolina, Texas, and California. Healthcare providers and patients who have used these specific impactor balls should contact Encore Medical, LP for further instructions regarding the recall.
The recalled product
- Product
- EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to…
- Manufacturer
- Encore Medical, LP
- Affected units
- 86
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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