Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1241-2018·Announced 2018-04-04

Encore Medical Recalls AltiVate Reverse Humeral Socket Shell Trials

Encore Medical is recalling AltiVate Reverse Humeral Socket Shell Trials due to broken or missing screws and retaining clips.

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. The hazard involves broken or missing components in a surgical trial instrument, which poses a risk of harm but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I).

Plain-English summary

Encore Medical, LP is recalling 387 units of AltiVate Reverse Instrumentation, Humeral Socket Shell Trial, Standard (Ref 804-06-152). The affected units were distributed nationwide in the United States. The specific lot codes for the recalled product are 183312L03, 200006L01, and 224643L01.

The recall was initiated because the product may have broken or missing screws and retaining clips. The source text indicates this issue may be due to screw tolerance and the material strength of the trial instrument. This orthopedic surgical instrument is used to replicate or trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants prior to implantation.

Healthcare providers and facilities that have received these products should stop using them and contact Encore Medical, LP for further instructions on the recall.

The recalled product

Product: AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard…
Manufacturer: Encore Medical, Lp
Category: Medical Device — Orthopedic Surgical Instrument
Hazard: broken-parts
missing-parts
Affected units: 387

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 (3)

Lot Codes: 183312L03
200006L01
224643L01

Distribution

Distributed nationwide across the United States.

Same manufacturer · Encore Medical, Lp

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Same hazard · broken parts