Z-0201-2013Class II

"Sharpoint IQ Geometry Slit Knife Angled, Bevel UpSurgical Specialties Corporation Reading, PA***REF...

Name: Z-0201-2013 "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF...
Creator: Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Published: 2012-08-15
License: https://open.fda.gov/license/

Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. / initiated 2012-08-15 / Terminated / root cause: manufacturing process

FDA source

Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. began a recall of "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery on 2012-08-15. FDA classified it as Class II and gives the reason as "Potential for bent tips". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0201-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-15
Posted: 2012-11-05
Terminated: 2014-01-13
Recalling firm: Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Product: "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery
Product code: GES Blade, Scalpel
Reason for recall: Potential for bent tips.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Angiotech sent an Urgent Product Recall Notification letter dated August 15, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the current inventory, segregate the affected lot numbers, and to return the identified product. Customers were asked to complete the attached Customer Acknowledgement Form and fax to the Quality Assurance department at 787-658-1073. If product was further distributed customers should notify their customers to whom they sold the affected product. Customers with questions should call 787-658-1800 option 2 ext. 1775 or 787-658-1800 option 2 ext 1807. For questions regarding this recall call 787-658-1800.
Quantity in commerce: 117,948 units (total)
Distribution: 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
Product codes and lots: MAFD350, M381400, M407870, M439070, M439090, M466140, M495140, M495190, M510800, M554700, M554740, M585650, M656720, M656730, MABL380, MABQ000, MADM740

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0201-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0201-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-05
Z-0202-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-05
Z-0203-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-05
Z-0204-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-05

Product code GES

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)