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U.S. Department of Health and Human Services

Class 2 Device Recall Sharpoint 2.2MM, ANGLED, DOUBLE BEVEL

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 Class 2 Device Recall Sharpoint 2.2MM, ANGLED, DOUBLE BEVELsee related information
Date Initiated by FirmApril 23, 2026
Date PostedJune 04, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2309-2026
Recall Event ID 98911
Product Classification Knife, ophthalmic - Product Code HNN
Product Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife
Code Information UDI-DI 00848782027514; Lot Number FA22CHQ
FEI Number 3011767135
Recalling Firm/
Manufacturer
SSC- Surgical Specialties Corporation
1690 Brandywine Ave Ste C
Chula Vista CA 91911-6072
For Additional Information ContactAlex Castillo
+1-619-6178100
Manufacturer Reason
for Recall
3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
FDA Determined
Cause 2
Mixed-up of materials/components
ActionOn August 22, 2026, Surgical Specialties Corp. (subsidiary of Corza Medical) issued a Urgent Medical Device recall notification via E.Mail to affected consignees. Surgical Specialties ask consignees to take the following actions: 1. Immediately examine your inventory and quarantine product subject to recall. We request the return of any affected product that may still be in your inventory. We will replace the product 2. Recall Acknowledgement & Receipt Please complete and return the attached Medical Device Recall Acknowledgement & Receipt form as soon as possible to returns.corzaeye@corza.com. 3. To initiate a return, contact returns.corzaeye@corza.com to process the request. 4. If you have any questions related to product quality, contact us at complaints@corza.com.
Quantity in Commerce1818 units
DistributionWorldwide - US Nationwide distribution in the states of Texas, Utah, Michigan and the countries of Turkey, Germany, Romania, Poland, United Kingdom.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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