Reverse Shoulder Prosthesis Implants Recalled Over Incorrect Labeling
Encore Medical, LP is recalling 20 Reverse Shoulder Prosthesis implants due to incorrect labeling. The recall affects nationwide distribution across multiple US states.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. Per the rubric, FDA Class II recalls with reported adverse events or risk of harm to patients qualify for a severity score of 4 (Severe).
Plain-English summary
Encore Medical, LP is recalling 20 Reverse Shoulder Prosthesis (RSP) STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus implants, model number 509-00-036. The recalled implants have lot code 378P1382 and GTIN 00888912144544.
The recall is due to incorrect labeling on the knee and humeral socket implants. The FDA has classified this recall as Class II, meaning the device 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 facilities and distributors should immediately quarantine the recalled implants and contact Encore Medical, LP to arrange for return or replacement. Patients who have received these implants should consult their healthcare provider if they have any concerns.
The recalled product
- Product
- Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
- Manufacturer
- Encore Medical, LP
- Hazard
- Affected units
- 20
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: 378P1382 GTIN: 00888912144544
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.
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