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.
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 3/5 (High).
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
- 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
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.
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