The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0671-2022·Announced 2022-03-02

Shoulder Implant Stem Coating Defect Due to Invalid Rework Process

Biomet is recalling a shoulder implant stem due to a manufacturing defect in the porous plasma coating. Internal testing indicated the coating may not have sufficient adhesion strength after an unvalidated waterjet rework process.

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: This is an FDA Class II medical device recall for an orthopedic implant with a manufacturing defect that could compromise device function. No illnesses or injuries have been reported; the risk is based on internal testing indicating potential coating adhesion failure.

Plain-English summary

Biomet, Inc. is recalling the Comprehensive Shoulder System Primary Shoulder Stem (11 MM, 55 MM Long, Item Number 113611) due to a manufacturing defect affecting the porous plasma coating. The recall applies to Lot Number 821170.

The defect resulted from an incorrect rework operation. The porous plasma coating was applied or reapplied at a vendor facility, then reworked through Biomet's internal waterjet process. Internal testing determined that this waterjet rework process is not validated for vendor-coated parts, and the coating may lack sufficient adhesion strength.

The affected product was distributed worldwide, including throughout the United States, Canada, Ecuador, and the Netherlands.

The recalled product

Product
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
10

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 Number: 821170 UDI: (01)00880304554122(17) 280825(10)821170

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Biomet, Inc. 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 8 products in this recall →

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