Shoulder prosthesis humeral socket inserts recalled over incorrect implant labeling
Encore Medical is recalling Reverse Shoulder Prosthesis humeral socket inserts, catalogue number 509-00-432, because knee and humeral socket implants contain incorrect labeling.
What this means for you
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: incorrect labelling on a surgical implant risks the wrong component being fitted, and no injuries are stated in the source.
Plain-English summary
Encore Medical, LP is recalling the Reverse Shoulder Prosthesis (RSP) Humeral Socket Insert, 32 mm +4 mm, Standard HXe-plus, model/catalogue number 509-00-432. About 20 implants were distributed in Virginia, Tennessee, Illinois, Indiana, Michigan, Colorado, Wyoming, Montana, Rhode Island, Massachusetts, New Jersey, Pennsylvania, Missouri, Oklahoma, Louisiana, Florida and California. The FDA has classified this recall as Class II.
Knee and humeral socket implants contain incorrect labeling.
Affected product is lot 385P1263, GTIN 00888912144575.
Facilities can identify affected implants by the catalogue number, lot code and GTIN above, and may contact Encore Medical, LP for further information.
The recalled product
- Product
- Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
- Manufacturer
- Encore Medical, LP
- 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: 385P1263 GTIN: 00888912144575
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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