Knee and Humeral Socket Implants Recalled for Incorrect Labeling
Encore Medical, LP is recalling 14 EMPOWR 3D KNEE implants because they contain incorrect labeling. The recall affects US nationwide distribution.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which per the rubric warrants a score of 4 (Severe) when hospitalization reports or significant injury are present. The source text does not mention any reported illnesses or injuries, but the FDA Class II classification places this recall in the Severe category.
Plain-English summary
Encore Medical, LP is recalling 14 EMPOWR 3D KNEE INS, 7L 16MM, VE implants, model number 341-16-707, lot code 151T1055A. The implants contain incorrect labeling, according to the recall notice.
The recall was classified as Class II by the FDA, meaning the product could cause temporary or medically reversible adverse health consequences if used as labeled.
The recalled implants were distributed nationwide in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, and CA.
Healthcare providers and recipients should contact Encore Medical, LP regarding the incorrect labeling. Consumers with questions should follow up with their healthcare provider or surgeon.
The recalled product
- Product
- Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
- Manufacturer
- Encore Medical, LP
- Hazard
- Affected units
- 14
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)
- Lot Code: Lot: 151T1055A GTIN: 00888912167147
Distribution
Part of a larger recall action
This product is one of 3 recalled by Encore Medical, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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