The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2058-2015·Announced 2015-07-22

Biomet Recalls 50 A.L.P.S. Cortical Locking Screws Due to Packaging Defect

Biomet, Inc. is recalling 50 A.L.P.S. 3.5mm x 60 mm Cortical Locking Screws because the sterile packaging was not sealed, posing a risk of infection.

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 is classified as FDA Class II. The hazard is a risk of infection from an unsterile implant, which is a significant health risk, but the source text does not report any actual illnesses, injuries, or hospitalizations, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biomet, Inc. is recalling 50 units of the A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw, a bone fixation screw. The recall is due to a defect where the sterile packaging was not sealed. The specific part number for the affected units is 856135060, and the lot number is 061300.

The distribution of these units was limited to international markets, specifically the Netherlands and Japan. There were no domestic distributions in the United States. The primary hazard associated with this recall is that the implantation of an unsterile screw may lead to infection.

Healthcare providers and patients who have used or possess these specific units should contact Biomet, Inc. for further instructions on how to proceed. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
50

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)

  • Part number:856135060 Lot: 061300

Distribution

Distribution scope not specified by the agency.

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