Gentle Threads Interference Screw 9x35mm Full Thread recallZ-1945-2015 · Biomet, Inc. · initiated Jun 3, 2015
Class II Terminated All recalls posted in July 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.
FDA root cause category: Mixed-up of materials/components
What the company is doing
On 6/3/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for locating and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Recall details
- Recall number
- Z-1945-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 3, 2015
- Posted by the FDA
- Jul 1, 2015
- Recalling firm
- Biomet, Inc.
- Quantity
- 41 units
- Product code
- HWC
- FDA submissions
- K982497
- Distribution
- Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.
Product description
Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
Code information (models, lots, serial numbers)
Part Number: 905627 Lot: 753410
Other devices under the same FDA submission
6 devices cleared under K982497 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Gentle Threads 905612Biomet Orthopedics, LLC · Screw, fixation, bone1 recall7 reports
- Gentle Threads 905608Biomet Orthopedics, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE3 reports
- Gentle Threads 905604Biomet Orthopedics, LLC · Screw, fixation, bone2 reports
- Gentle Threads 905617Biomet Orthopedics, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE2 reports
- Gentle Threads 905616Biomet Orthopedics, LLC · Screw, fixation, bone1 report
- Gentle Threads 905605Biomet Orthopedics, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 71526).
- Z-1944-2015 · TerminatedGentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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