Biomet Microfixation Ref: 91-6103 "1.5mm" System High… recallZ-1943-2010 · Biomet Microfixation, Inc. · initiated Oct 5, 2009
Terminated All recalls posted in June 2010
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 Microfixation, 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
Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw.
FDA root cause category: Process design
What the company is doing
Biomet Microfixation notified each consignee by email and fax on 10/05/2009. Each consignee was asked to use the included Response Form to provide product disposition.
Recall details
- Recall number
- Z-1943-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 5, 2009
- Posted by the FDA
- Jun 30, 2010
- Recalling firm
- Biomet Microfixation, Inc.
- Quantity
- 91 units
- Product code
- JEY
- FDA submissions
- K953385
- Distribution
- US distribution: CA, CO, MI, and MO.
Product description
BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***. Bone screws used along with implantable bone plates for oral, cranio-maxillofacial procedures.
Code information (models, lots, serial numbers)
Lot 829760
Other devices under the same FDA submission
41 devices cleared under K953385 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- "1.5MM" SYSTEM 95-6104Biomet Microfixation, Inc · FASTENER, PLATE, CRANIOPLASTY30 reports
- "1.5MM" SYSTEM 95-1505Biomet Microfixation, Inc · COVER, BURR HOLE23 reports
- "1.5MM" SYSTEM 91-6105Biomet Microfixation, Inc · COVER, BURR HOLE20 reports
- THINFLAP SYSTEM 91-6704Biomet Microfixation, Inc · Plate, cranioplasty, preformed, alterable19 reports
- "1.5MM" SYSTEM 95-6105Biomet Microfixation, Inc · FASTENER, PLATE, CRANIOPLASTY16 reports
- "1.5MM" SYSTEM 91-6104Biomet Microfixation, Inc · Plate, cranioplasty, preformed, alterable9 reports
- "1.5MM" SYSTEM 91-6106Biomet Microfixation, Inc · COVER, BURR HOLE7 reports
- "1.5MM" SYSTEM 01-6482Biomet Microfixation, Inc · PLATE, BONE6 reports
- TMS SYSTEM 25-2005Biomet Microfixation, Inc · PLATE, BONE6 reports
- 1.5MM SYSTEM 91-6105XBiomet Microfixation, Inc · FASTENER, PLATE, CRANIOPLASTY5 reports
- 1.5MM SYSTEM 95-6105XBiomet Microfixation, Inc · Plate, cranioplasty, preformed, alterable4 reports
- "1.5MM" SYSTEM 01-6480Biomet Microfixation, Inc · PLATE, BONE3 reports
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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