Encore Medical, LP

Encore Medical's RSP Standard Humeral Socket Insert (36mm, HXe-plus model) was distributed with incorrect labeling. About 20 implants from a single lot were affected across multiple states. No injuries have been reported so far.

Encore Medical's EMPOWR 3D Knee implants (model 341-16-707, lot 151T1055A) were distributed with incorrect labeling that could affect proper surgical placement or identification. Fourteen implants were affected across multiple states. No injuries have been reported.

Encore Medical's RSP humeral socket insert (model 509-00-432, lot 385P1263) has incorrect labeling that could cause confusion during surgical implantation. This affects 20 implants distributed across multiple U.S. states. No injuries have been reported.

Encore Medical discovered that some packages of EMPOWR Acetabular System hip implant liners contained the wrong device inside—for example, a box labeled as one size contained a different size. This packaging error could force surgeons to delay surgery or perform additional procedures to swap out the correct implant.

Encore Medical discovered that some packages of knee tibial inserts and acetabular (hip socket) system components contain the wrong device inside. This packaging error could delay surgery or require unexpected revision surgery if the mismatch is not caught beforehand.