The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1093-2016·Announced 2016-03-16

Biomet Recalls Verso Shoulder Forked Retractors Due to Material Nonconformance

Biomet is recalling Verso Shoulder Forked Retractors because they were manufactured with 420 stainless steel instead of the specified 420 S29 material.

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, which typically involves a temporary or medically reversible adverse health consequence. The source text describes a material nonconformance (incorrect steel grade) without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

Biomet, Inc. is recalling the Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) under FDA recall number Z-1093-2016. The recall involves 1,261 units of the device, which is indicated for use in patients with a grossly deficient rotator cuff and severe arthropathy or previously failed shoulder joint replacement.

The recall was initiated because the retractor, supplied by Kirkstall Precision, was manufactured using W1.4034 (420 stainless) steel. This material does not conform to the 420 S29 specification indicated on the manufacturing print. Because all units manufactured to date used the nonconforming 420 stainless steel, all lots of Part Number 402852 are included in the scope of this recall.

The affected products were distributed worldwide, including in the United States and various international locations such as Australia, Canada, and Japan. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.

The recalled product

Product
Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder…
Manufacturer
Biomet, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
1,261

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)

  • all lots of PN: 402852

Distribution

Distributed in 31 states:

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