Modulift VBR Surgical Screwdriver Fails Due to Tip Deformation
Aesculap is recalling the Modulift VBR 4MM set screwdriver due to tip deformation during surgical engagement with implants. The device is distributed in CA, FL, GA, IL, OH, and MI.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II surgical instrument recall with a documented defect (tip deformation) that occurs during clinical use. No patient illnesses or injuries have been reported in the source material. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High severity.
Plain-English summary
The Modulift VBR Medium Instrument Set (part number ST-0441), specifically the 4MM set screw driver (MF790R, UDI-DI: 04046964067648), has been recalled by manufacturer Aesculap Implant Systems LLC.
The recall was initiated due to a device defect: the screwdriver deforms at the tip during engagement and manipulation of the implant when used in surgery. This deformation occurs during normal surgical use of the instrument.
The affected product was distributed in the United States to facilities in California, Florida, Georgia, Illinois, Ohio, and Michigan.
The recalled product
- Product
- MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
- Manufacturer
- Aesculap Implant Systems LLC
- Affected units
- 9
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 (1)
- UDI-DI: 04046964067648
Distribution
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