The Recall Desk
HighFDA (Devices)·Z-0675-2022·Announced 2022-03-02

Biomet Shoulder Implant Stem Coating Adhesion Defect Recall

Biomet is recalling shoulder implant stems due to improper rework of porous plasma coating, which may lack sufficient adhesion strength. Affected units may fail if the coating detaches.

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: FDA Class II medical device recall for a structural defect in orthopedic implant coating with potential for failure. No illnesses or injuries have been reported. The hazard represents risk-of-harm if coating adhesion fails, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biomet, Inc. is recalling the Comprehensive Shoulder System Mini Humeral Stem (Item Number 113632) due to a manufacturing defect. Affected units underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing found that the coating may not have sufficient adhesion strength.

The recall applies to all lots that were porous plasma coated or recoated at a vendor and then processed through Biomet's internal waterjet rework procedure. The waterjet rework process has not been validated for products coated by external vendors. Affected units are identified by Lot Number 327160 (UDI: 01008803044497491729081910327160).

The implant stems have been distributed worldwide, including throughout the United States and to Canada, Ecuador, and the Netherlands. Patients who have received this implant should consult with their healthcare provider about the recall and any necessary follow-up care.

The recalled product

Product
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic / Joint 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: 327160 UDI: (01)00880304449749(17)290819(10)327160

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 · adhesion failure

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