Reported Jan 21, 2015 · Terminated
Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral…
Biomet Spine, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomet Spine, LLC · 310 Interlocken Pkwy Ste 120 · Broomfield, CO · 80021-3464
Is this the product you have?
- Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
- Lot codes and dates
- Model 8630-0102 Anchored
- Lateral Retractable Drill lot TU00049
February 252013
- and TU00155
July 312013
- Amount recalled
- 15
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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