High FDA (Devices)·Z-2606-2023·Announced 2023-09-27

DJO Surgical Reverse Shoulder System Components Recalled Due to Missing Sterilization

Reverse shoulder implant components were shipped without final sterilization, potentially leading to infection and possible revision surgery if implanted. Encore Medical is recalling 64 units distributed across the US and internationally.

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: This FDA Class II recall involves a critical process failure (missing sterilization) on an implantable orthopedic device with serious infection risk requiring potential surgical intervention. However, no illnesses, injuries, or hospitalizations have been reported. This matches the rubric criterion for high-risk products where injury has not yet been reported.

Plain-English summary

Encore Medical is recalling DJO Surgical Reverse Shoulder System (RSP) components due to a manufacturing process failure: orthopedic device components were not subjected to final sterilization before shipment. The recalled components include Semi Humeral Socket Inserts (32mm), Glenoid Baseplate HA-Coat (6.5mm X 30mm), and Glenoid Neutral Head assemblies (36mm).

If implanted, non-sterile components may lead to varying degrees of infection. Potential consequences include the need for treatment, prolonged medical monitoring, and possible revision surgery. The recall affects 64 units distributed throughout the United States (including Puerto Rico and multiple states), as well as Sweden, Australia, France, United Kingdom, Colombia, and Germany.

Patients who received these implants should contact their healthcare provider immediately to determine if their device is part of this recall. Specific lot numbers and reference identification codes are available through Encore Medical and the FDA. Healthcare providers should cease use of affected inventory and consider contacting patients who may have received these components.

The recalled product

Product: DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101
Manufacturer: Encore Medical, LP
Category: Medical Device — Orthopedic Implant
Hazard: infection-risk
sterilization-failure
Affected units: 64

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 (7)

REF/UDI-DI/Lot/Expiration: 508-01-032/00888912024693/859C1190/April 29
2027
508-32-104/00888912024754/866C3153/May 25
2029 and 866C3147/April 3
2029
508-36-101/869C3539/April 30
2028

Distribution

Distributed in 26 states:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Same manufacturer · Encore Medical, LP

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