—#203662

Product

Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K121426
Affected lot / code info: GTIN: 7613327300291; Lot Numbers: 200507008

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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 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 Instruments.recalls@stryker.com 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 inst.stryker.cs@stryker.com.

Recalling firm

Firm: Stryker Corporation
Address: 1941 Stryker Way, Portage, Michigan 49002-9711

Distribution

Distribution pattern: US Nationwide. Australia, Canada, Japan, Korea, Singapore.

Timeline

Recall initiated: 2023-09-11
Posted by FDA: 2023-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203662. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.