The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1131-2021·Announced 2021-02-24

Biomet Recalls Mislabelled 25mm Shoulder Prosthesis Central Screws

Biomet is recalling 49 units of 25mm central screws for shoulder prostheses because they were mislabeled as 25mm but are actually 40mm.

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: The recall involves a medical device with a significant labeling error (40mm screw labeled as 25mm) that poses a risk of harm during implantation, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Biomet, Inc. is conducting a lot-specific recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. The recall involves 49 units of the device, which is a sterile screw intended for implantable shoulder prosthesis assembly and/or fixation.

The recall was initiated after a complaint investigation determined that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw. This labeling error could result in the implantation of an incorrect screw size during a surgical procedure.

The affected product is identified by Model No. 115395 and Lot No. 077170. The recall covers US Nationwide distribution, including the states of MS, MN, KY, FL, MI, OH, AZ, IL, WI, CA, UT, and TN. Healthcare providers and patients should verify the lot number of any implanted or stored screws and contact Biomet or the FDA for further instructions.

The recalled product

Product
Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
49

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 (3)

  • Model No.: 115395
  • Lot No.: 077170
  • UDI: (01) 00880304677074 (17) 301010 (10) 077170

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

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