The Recall Desk
HighFDA (Devices)·Z-0203-2013·Announced 2012-11-14

FDA Recalls Sharpoint IQ Slit Knives Due to Potential Bent Tips

Surgical Specialties Puerto Rico Inc. is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.

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 is classified as FDA Class II. The hazard involves a structural defect (bent tips) in a surgical instrument, which poses a risk of harm during ophthalmic surgery, but no specific injuries or illnesses are reported in the source text.

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 being conducted because the product has a potential for bent tips.

The recall involves 117,948 units of the product. The items were distributed worldwide, including to specific states in the United States and numerous international countries. The affected product codes are MABQ150, MAGS310, and MAJC690.

The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected 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 72-3040***" Ophthalmic surgery
Manufacturer
Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Category
Medical Device — Surgical Instruments
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 (3)

  • MABQ150
  • MAGS310
  • MAJC690

Distribution

Distributed in 12 states:

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.

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Same hazard · structural defect

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