The Recall Desk
HighFDA (Devices)·Z-0673-2022·Announced 2022-03-02

Biomet Shoulder Stem Implants Recalled for Coating Adhesion Defect

Biomet is recalling certain shoulder stem implants due to potential insufficient adhesion strength in the porous plasma coating. An improper rework process may have compromised the coating's integrity.

What this means for you

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 a Class II recall of an orthopedic implant with a confirmed structural defect affecting coating adhesion. While no illnesses or injuries have been reported, this is a risk-of-harm product where coating failure could require revision surgery. Per the rubric, risk-of-harm products without reported injury are scored as High (3).

Plain-English summary

Biomet, Inc. is recalling the Comprehensive Shoulder System Primary Shoulder Stem (Micro Length, Porous Plasma, 18 MM, 55 MM Long, Item Number 113618) due to a coating adhesion defect.

The affected implants underwent an incorrect rework operation at an internal waterjet facility. Internal testing identified that the porous plasma coating on affected units may not have sufficient adhesion strength. The waterjet rework process used was not validated for products that had been coated by an external vendor, creating a risk of coating failure.

The recall affects Lot 732370 and all lots with porous plasma coating or recoating from external vendors that were subsequently reworked through the internal waterjet process. Worldwide distribution includes the United States, Canada, Ecuador, and the Netherlands.

Patients with these implants should consult their physician or the implant manufacturer for guidance on appropriate follow-up.

The recalled product

Product
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618
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: 732370 UDI: (01)00880304554191(17) 290802(10)732370

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 →

Related recalls

Same manufacturer · Biomet, Inc.

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Same hazard · coating defect

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