Surgical Specialties Recalls Sharpoint IQ Slit Knives Due to Bent Tips
Surgical Specialties is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.
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: The recall involves a risk-of-harm product (surgical instrument) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. is recalling Sharpoint IQ Geometry Slit Knives, Angled, Bevel Up (REF 72-3240). The recall is due to a potential for bent tips on the surgical instruments.
The recall involves 117,948 units. The products were distributed worldwide, including in the United States (DE, IL, NC, CA, CO, GA, KY, PA, MD, MN, NY, and MA) and internationally to numerous countries such as Austria, UAE, China, Argentina, Italy, and others. Specific lot codes associated with the recall include MAKR840, MALZ570, MALZ580, MAMQ990, MAMR000, MANP250, MAPR320, and MAQD910.
Healthcare providers and consumers should stop using these products and contact the recalling firm for further instructions.
The recalled product
- Product
- "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery
- Hazard
- Affected units
- 117,948
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)
- MAKR840
- MALZ570
- MALZ580
- MAMQ990
- MAMR000
- MANP250
- MAPR320
- MAQD910
Distribution
Part of a larger recall action
This product is one of 4 recalled by Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
See all →- ModerateSurgical Specialties Recalls Sharpoint IQ Slit Knives Due to Bent Tips
FDA (Devices) · 2012-11-14
- ModerateFDA Recalls Sharpoint IQ Slit Knives Due to Potential Bent Tips
FDA (Devices) · 2012-11-14
- HighFDA Recalls Sharpoint IQ Slit Knives Due to Potential Bent Tips
FDA (Devices) · 2012-11-14
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