Reported May 16, 2018 · Terminated
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES
Medtronic Sofamor Danek USA Inc.
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: Medtronic Sofamor Danek USA Inc · 1800 Pyramid Pl · Memphis, TN · 38132-1703
Is this the product you have?
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES
3 of 3 products
| Model / number | Product as published |
|---|---|
6975205 | 5mm |
6975206 | 6mm |
6975207 | 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use. |
- Lot codes and dates
- a) REF 6975205, 5mm; UDI 00643169752979 Lot Number ID17K018 b) REF 6975206, 6mm; UDI 00643169752962 Lot Number ID17J009 c) REF 6975207, 7mm
- UDI 00643169752955 Lot Numbers
ID17K007ID17L035
- Amount recalled
- 231 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.
This product could cause temporary or reversible health problems — stop using it.
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