| | Class 2 Device Recall Sharpoint 2.2MM, ANGLED, DOUBLE BEVEL |  |
| Date Initiated by Firm | April 23, 2026 |
| Date Posted | June 04, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-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 Contact | Alex 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 |
| Action | On 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 Commerce | 1818 units |
| Distribution | Worldwide - US Nationwide distribution in the states of Texas, Utah, Michigan and the countries of Turkey, Germany, Romania, Poland, United Kingdom. |
| Total Product Life Cycle | TPLC Device Report |
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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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