Agency classClass IIOur severity:High FDA (Devices)·Z-0179-2016·Announced 2015-11-04

Encore Medical Recalls Turon Shoulder Impaction Fixtures Due to Material Wear

Encore Medical is recalling 277 Turon Shoulder Impaction Fixtures because polymer material wore off during assembly, potentially contaminating the implant.

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: The recall involves a medical device defect where foreign material (polymer) transfers to an implant, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Encore Medical, Lp is recalling 277 units of the Turon Shoulder Impaction Fixture (REF 804-15-102). These medical devices are used in operating rooms to assemble shoulder implant systems, specifically connecting the humeral head to the humeral neck and stem.

The recall was initiated because impaction forces during the assembly process caused the black acetal copolymer material from the fixture to wear off. This material transferred to the lateral surface of the titanium plasma spray coating on the Humeral Stem. The affected units are identified by Lot # 52748L02A and were distributed nationwide.

Healthcare facilities and consumers should stop using the affected Turon Shoulder Impaction Fixtures immediately. The source text does not specify a remediation action such as return or destruction, but the presence of foreign polymer material on the implant surface constitutes a defect requiring cessation of use.

The recalled product

Product: Turon Shoulder Impaction Fixture REF 804-15-102 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 subsequently to…
Manufacturer: Encore Medical, Lp
Category: Medical Device — Orthopedic Implant Assembly
Hazard: foreign-material
material-wear
Affected units: 277

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 →

Same manufacturer · Encore Medical, Lp

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