The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0672-2022·Announced 2022-03-02

Biomet Shoulder Implant Stem Recalled for Inadequate Coating Adhesion

Biomet is recalling a Comprehensive Shoulder System implant component due to a defect in the porous plasma coating. The coating may not have sufficient adhesion strength, compromising the implant's structural integrity.

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: FDA Class II recall involving a structural defect in orthopedic implant coating adhesion. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High (3) severity score.

Plain-English summary

Biomet, Inc. is recalling 12 units of the Comprehensive Shoulder System Primary Shoulder Stem (Item Number 113614, Lot Number 439470) due to a manufacturing defect affecting the porous plasma coating.

The recalled products underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the coating may not have sufficient adhesion strength. The issue affects all products that were porous plasma coated or recoated at a vendor and then reworked through Biomet's internal waterjet rework process. Biomet determined that the waterjet rework process for porous plasma coating is not validated for products that were initially coated by a vendor.

The affected implant components were distributed worldwide, including in the United States, Canada, Ecuador, and the Netherlands.

The recalled product

Product
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
12

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: 439470 UDI: (01)00880304554153(17) 290803(10)439470

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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