Medtronic Prestige LP Cervical Disc Drill Guides Recalled for Breakage
Medtronic is recalling specific drill guides for the Prestige LP Cervical Disc System because they may cause drill bits to break during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect (drill bit breakage) that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling specific drill guides used with the Prestige LP(TM) Cervical Disc System. The recall involves 231 units of 5mm, 6mm, and 7mm drill guides that were distributed nationwide in the United States.
The recall was initiated after the firm received complaints that drill bits broke during use. An investigation determined that the interaction between the drill guide and the drill bit may lead to this breakage. The affected products are identified by specific reference numbers and lot numbers listed in the agency's records.
These reusable instruments are intended for the surgical implantation of the Prestige LP Cervical Disc. The source text does not specify instructions for consumers or healthcare providers regarding the immediate handling of these devices, but the recall indicates a defect in the interaction between the components.
The recalled product
- 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 Cervic
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 231
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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
Distribution
Distributed nationwide across the United States.
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