The Recall Desk
ModerateFDA (Devices)·Z-0201-2013·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 they may have bent tips. The recall affects 117,948 units distributed worldwide.

What this means for you

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, but the source text does not report any hospitalizations or significant injuries, fitting the criteria for a moderate severity score involving a defect without reported harm.

Plain-English summary

Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. is recalling Sharpoint IQ Geometry Slit Knives, Angled, Bevel Up (REF 72-2740). The recall is due to a potential for bent tips on the surgical instruments. The agency classifies this as a Class II recall.

The recall involves 117,948 units. These ophthalmic surgery instruments were distributed worldwide, including in the United States and various international locations. Specific lot codes associated with the recall include MAFD350, M381400, and others listed in the agency records.

Healthcare providers and consumers should stop using the affected products and contact the recalling firm for instructions on return or replacement. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" 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 (17)

  • MAFD350
  • M381400
  • M407870
  • M439070
  • M439090
  • M466140
  • M495140
  • M495190
  • M510800
  • M554700
  • M554740
  • M585650
  • M656720
  • M656730
  • MABL380
  • MABQ000
  • MADM740

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 · bent tip

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