Recall Z-0257-2024 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015
| Date | Nov 7, 2023 (initiated Sep 11, 2023) |
| Status | Open, Classified |
| Reason | An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life. |
| Root cause | Under Investigation by firm |
| Action | An URGENT Medical Device Recall notification letter was sent to customers on 9/11/23. Actions to be taken 1. Immediately check your inventory to locate and quarantine any affected products found at your facility. 2. Sign and return the enclosed Business Response Form (BRF) by email to Instruments.recalls@stryker.com, even if affected product is no longer in inventory. 3. Upon receipt of the completed BRF, a shipping label will be provided to return any recalled product on-hand and Stryker will contact you to arrange for replacement of your product(s). 4. Maintain awareness of this communicati |
| Quantity | 2,321 total units |
| Distribution | US Nationwide. Australia, Canada, Japan, Korea, Singapore. |
| FDA record | Open on fda.gov |