Encore Medical Recalls Reverse Shoulder Prosthesis Stem Impaction Fixtures
Encore Medical is recalling 634 units of Reverse Shoulder Prosthesis Stem Impaction Fixtures because polymer wear from the fixtures can damage the titanium coating on humeral stems during assembly.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves material wear during assembly that could affect the implant's coating, representing a moderate risk of adverse health consequences.
Plain-English summary
Encore Medical, Lp is recalling 634 units of the Reverse Shoulder Prosthesis Stem Impaction Fixture (REF 804-03-053). The affected product is identified by Lot # 52748L02A and was distributed nationwide. These fixtures are used in the operating room to assemble shoulder prosthesis systems for implant.
The recall was initiated because the impaction forces used during assembly caused the black acetal copolymer from the Impaction Fixture to wear off onto the lateral surface of the Humeral Stem's titanium plasma spray coating. This wear can compromise the integrity of the stem's coating.
The recall is classified as Class II by the FDA. Healthcare providers and facilities that have received these fixtures should stop using them and contact Encore Medical for instructions on return or disposal.
The recalled product
- Product
- Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then…
- Manufacturer
- Encore Medical, Lp
- Affected units
- 634
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 # 52748L02A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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