Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-010
FDA Recall Z-0246-2024 · Posted 2023-11-07
Recalling FirmStryker Corporation
Recall StatusOpen, Classified
Product CodeGEI
Date Initiated2023-09-11
Product Quantity2,321 total units
Reason for Recall
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.
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 [email protected], 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 communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly.
Please contact Jordan Anderson at (269) 800-1347 or [email protected] with questions or concerns.
For reporting any serious adverse events or product quality problems contact Stryker at 1-800-253-3210, ext. 5555 8:00 A.M. to 7:00 P.M. (Eastern Time), Monday Friday or by email at [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide. Australia, Canada, Japan, Korea, Singapore.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.