Sharpoint microsurgical knives labeled 2.2mm actually measure 3.0mm
Sharpoint 2.2 mm angled double-bevel microsurgical knives are being recalled because 3.0 mm knives were labeled and packaged as 2.2 mm. 1,818 units affected.
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: FDA Class II recall where a surgical blade is a larger size than its label states, a risk of harm with no injuries reported in the source.
Plain-English summary
The Sharpoint 2.2 mm angled, double-bevel microsurgical knife, model/catalog number 72-2231, UDI-DI 00848782027514, is being recalled. The action covers 1,818 units in lot FA22CHQ.
The stated reason is that 3.0 mm surgical knives were labeled and packaged as 2.2 mm surgical knives. The FDA classified the action as Class II.
Distribution was worldwide, including within the United States in Texas, Utah and Michigan. The knives are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog number, UDI-DI and lot number above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife
- Manufacturer
- SSC- Surgical Specialties Corporation
- Category
- Medical Device — Surgical knife
- Hazard
- mislabeled-size
- wrong-dimension
- surgical-instrument
- class-ii
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 (2)
- UDI-DI 00848782027514
- Lot Number FA22CHQ
Distribution
Distributed nationwide across the United States.
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