Moderate FDA (Devices)·Z-1412-2017·Announced 2017-03-15

Encore Medical Recalls Turon Impaction Fixtures Due to Material Wear

Encore Medical is recalling 297 Turon Impaction Fixtures because polymer material wore off during assembly, potentially affecting the humeral stem coating.

What this means for you

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. The source text describes a manufacturing defect involving material wear but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Encore Medical, Lp is recalling 297 units of the Turon Impaction Fixture. The recall was initiated because the impaction forces used during the Turon assembly process caused the black acetal copolymer polymer from the fixture to wear off onto the lateral surface of the Humeral Stem titanium plasma spray coating.

The affected units were distributed in the United States, South Korea, Australia, Canada, the United Kingdom/Ireland, and Germany. Specific lot codes for the recalled units are listed in the agency's structured data.

Healthcare providers and consumers should stop using the affected Turon Impaction Fixtures and contact Encore Medical, Lp for further instructions on the recall.

The recalled product

Product: Turon Impaction Fixture
Manufacturer: Encore Medical, Lp
Category: Medical Device — Orthopedic Instrument
Hazard: material-wear
manufacturing-defect
Affected units: 297

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 (20)

101521L01
115670L18
128092L10
136172L07
136172L08
141511L22
37369L10A
37369L10B
37837L23A
37837L23B
37837L23C
37837L23D
51103L05E
51103L05F
52748L02A
52748L02B
52748L02C
52748L02D
52748L02E
52748L02F

Distribution

Distribution scope not specified by the agency.

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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