Recall Z-1641-2018
Medtronic Sofamor Danek USA Inc · initiated March 13, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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
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.
FDA-determined cause: Under Investigation by firm
Action taken
Medtronic distributed a voluntary removal notice via FedEx courier service to impacted U.S. consignees on 13MARCH 2018. The notice requested the following: "Instructions to Customers: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via fax to 763-367-8134, or via e-mail to rs.sdmriskmgt@medtronic.com. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return of affected product."
Details
- Recall number
- Z-1641-2018
- Initiated
- March 13, 2018
- Terminated
- November 2, 2020
- Product code
- MJO – Prosthesis, Intervertebral Disc
- Quantity
- 231 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- Medtronic Sofamor Danek USA Inc, Memphis, TN