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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. is recalling Sharpoint IQ Geometry Slit Knives (Angled, Bevel Up) used for ophthalmic surgery. The recall is due to a potential for bent tips on the instruments.
The recall involves 117,948 units. These products were distributed worldwide, including in the United States and numerous international locations. Specific lot codes associated with the recall include M342500, M342510, M415840, M439130, M446040, M495130, M495160, M510810, M553460, M553470, M553480, M585640, M585740, M652760, M652770, M652780, MADP160, and MADP170.
Healthcare providers and consumers should stop using these specific instruments and contact the manufacturer for further instructions or a replacement.
The recalled product
- Product
- "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" 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 (18)
- M342500
- M342510
- M415840
- M439130
- M446040
- M495130
- M495160
- M510810
- M553460
- M553470
- M553480
- M585640
- M585740
- M652760
- M652770
- M652780
- MADP160
- MADP170
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 →- HighSurgical 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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