The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1944-2015·Announced 2015-07-08

Biomet Recalls Gentle Threads Interference Screws Due to Lot Mixing

Biomet is recalling 53 units of Gentle Threads Interference Screws because they were mixed with a different size, posing a risk of surgical failure.

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 where using the incorrect size may lead to surgical failure, revision surgery, or delay in surgery. This fits the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biomet, Inc. is recalling 53 units of the Gentle Threads Interference Screw 10x25mm Round Head (Part Number 905620, Lot 824610). The recall is due to the product being mixed with a different size screw, specifically the Gentle Threads Interference Screw 9x35mm Full Thread (Part Number 905627, Lot 753410).

The use of the incorrect screw size may lead to various failures, which could ultimately result in revision surgery or a delay in surgery. These screws are used for soft tissue reattachment procedures.

The affected units were distributed internationally to Australia, Mexico, Chile, Costa Rica, the Netherlands, and Brazil. No domestic distribution is reported. Healthcare providers and patients should verify the part and lot numbers of their inventory and contact Biomet for instructions on returning the affected units.

The recalled product

Product
Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Screws
Hazard
Affected units
53

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: 905620 Lot: 824610

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Biomet, Inc.

See all →

Same hazard · surgical failure

See all →

Similar recalls