Z-1641-2018 Class II Terminated
FDA device recall Z-1641-2018 was initiated by Medtronic Sofamor Danek USA Inc on Mar 13, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Nov 2, 2020). Affected quantity: 231 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Mar 13, 2018
- Termination Date
- Nov 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 231 units
Product Description
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 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.
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution
Code Information
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: ID17K007, ID17L035
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1641-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026