Biomet Gentle Threads Interference Screw Recall Due to Product Mix-Up
Biomet is recalling Gentle Threads Interference Screws because two different part numbers were mixed. Using the incorrect screw may lead to failure or revision surgery.
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: The recall is classified as FDA Class II and involves a risk of harm (revision surgery or delay) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 41 units of Gentle Threads Interference Screw 9x35mm Full Thread (Part Number: 905627, Lot: 753410). The recall is due to a product mix-up where these screws were mixed with Gentle Threads Interference Screw 10x25mm Round Head (Part Number: 905620, Lot: 824610).
The FDA classifies this as a Class II recall. The source text states that if the incorrect screw is used, various failures may occur, which may ultimately lead to revision surgery or a delay in surgery. No specific injuries or illnesses are reported in the source text.
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 number and lot number of the screws in use to ensure they are not using the affected product.
The recalled product
- Product
- Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
- Manufacturer
- Biomet, Inc.
- Affected units
- 41
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: 905627 Lot: 753410
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.
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