Medtronic Sofamor Danek USA Inc: 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: T

Is my product affected?

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 i

• UPC 00643169752979
• UPC 00643169752962
• UPC 00643169752955

Check against the official notice below — it lists the full affected range.

What happened

Medtronic Sofamor Danek USA Inc. is recalling drill guides for the Prestige LP Cervical Disc System after receiving complaints that drill bits broke during use. The company's investigation found that the interaction between the drill guide and drill bit could cause the drill bit to break. The recall involves 231 units of three different drill guide sizes (5mm, 6mm, and 7mm) that were distributed nationwide, with specific lot numbers identified for each size.

The recalled drill guides have the following reference numbers and lot codes: REF 6975205 (5mm, Lot ID17K018), REF 6975206 (6mm, Lot ID17J009), and REF 6975207 (7mm, Lots ID17K007 and ID17L035). The source document does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: US Nationwide Distribution Quantity: 231 units Lot/code info: 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

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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