CLASS II Device recall · Reported 14 Nov 2012 · FDA Enforcement Report
"***Sharpoint IQ Geometry Slit Knife Angled recalled
Surgical Specialties Puerto Rico is recalling "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation, distributed in 11 states. The recall was initiated on 15 Aug 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0201-2013
- FDA event ID
- 62945
- Recalling firm
- Surgical Specialties Puerto Rico, Aguadilla, PR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Aug 2012
- FDA classified
- 5 Nov 2012
- Reported
- 14 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 15 Aug 2012 | Recall initiated by company | |
| 5 Nov 2012 | Classified by FDA | +82 days |
| 14 Nov 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for bent tips.
Product as listed by the FDA
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery
Where it was distributed
Worldwide Distribution - USA including DE,IL, NC, CA, CO, GA, KY, PA, MD, MN, NY, and MA and internationally to Austria, UAE, China, Argentina, Italy, Taiwan, Czech Republic, Australia, UK, India, Germany, Spain, France, South Africa, Malaysia, Japan, Lebanon, Korea, Greece, Saudi Arabia, Switzerland, Pakistan, Tunisia, Serbia, Morocco, Netherlands, Portugal, Truk, Belgium, and New Zealand
CaliforniaColoradoGeorgiaIllinoisKentuckyMassachusettsMarylandMinnesotaNorth CarolinaNew YorkPennsylvania
Questions about this recall
Why was it recalled?
Potential for bent tips.
Which lots are affected?
MAFD350, M381400, M407870, M439070, M439090, M466140, M495140, M495190, M510800, M554700, M554740, M585650, M656720, M656730, MABL380, MABQ000, MADM740
Where was it sold?
Worldwide Distribution - USA including DE,IL, NC, CA, CO, GA, KY, PA, MD, MN, NY, and MA and internationally to Austria, UAE, China, Argentina, Italy, Taiwan, Czech Republic, Australia, UK, India, Germany, Spain, France, South Africa, Malaysia, Japan, Lebanon, Korea, Greece, Saudi Arabia, Switzerland, Pakistan, Tunisia, Serbia, Morocco, Netherlands, Portugal, Truk, Belgium, and New Zealand
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 62945This product is part of a recall event; the main page for the event is "***Sharpoint IQ Geometry Slit Knife Angled recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | "***Sharpoint IQ Geometry Slit Knife Angled recalled | Surgical Specialties Puerto Rico | Other | 11 states | |
| CLASS II | "***Sharpoint IQ Geometry Slit Knife Angled recalled | Surgical Specialties Puerto Rico | Other | 11 states | |
| CLASS II | "***Sharpoint IQ Geometry Slit Knife Angled recalled | Surgical Specialties Puerto Rico | Other | 11 states |
More recalls from Surgical Specialties Puerto Rico
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | "***Sharpoint IQ Geometry Slit Knife Angled recalled | Surgical Specialties Puerto Rico | Other | 11 states |
| Device | CLASS II | "***Sharpoint IQ Geometry Slit Knife Angled recalled | Surgical Specialties Puerto Rico | Other | 11 states |
| Device | CLASS II | "***Sharpoint IQ Geometry Slit Knife Angled recalled | Surgical Specialties Puerto Rico | Other | 11 states |
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| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |