FDA Medical Device Recalls (openFDA)
Stryker Corporation: Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005
- Recall number
- Z-0252-2024
- Recalling firm
- Stryker Corporation
- Product
- Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005
- Status
- Open, Classified
- Initiated
- 2023-09-11
- Posted
- 2023-11-07
- Terminated
- not on file
- 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 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.
- Quantity
- 2,321 total units
- Distribution
- US Nationwide. Australia, Canada, Japan, Korea, Singapore.
- Lot, serial or model codes
- GTIN: 7613327300277; Lot Numbers: 201008016, 201015014, 201029008, 201210016
- 510(k) numbers
- ["K121426"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3015967359
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28