FDA Medical Device Recalls (openFDA)
Stryker Instruments Division of Stryker Corporation: Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Stryker Instruments, Kalamazoo, MI 49001 USA, (269) 323-7700 (800) 253-3210, Sterile, Single Use, Rx ONLY For Functional Endoscopic Sinus Surgery for the incision of soft and osseous tissue in the sinus cavities, open plastic, and reconstructive surgery of the head and neck.
- Recall number
- Z-2794-2011
- Recalling firm
- Stryker Instruments Division of Stryker Corporation
- Product
- Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Stryker Instruments, Kalamazoo, MI 49001 USA, (269) 323-7700 (800) 253-3210, Sterile, Single Use, Rx ONLY For Functional Endoscopic Sinus Surgery for the incision of soft and osseous tissue in the sinus cavities, open plastic, and reconstructive surgery of the head and neck.
- Status
- Terminated
- Initiated
- 2011-06-13
- Posted
- 2011-07-12
- Terminated
- 2011-08-03
- Reason
- Recalled device was packaged with the incorrect angled blade. The labeling indicates a 12 degree angle but the product has a 40 degree angle.
- Root cause
- Labeling mix-ups
- Action
- Stryker Instruments Division of Stryker CorporationOn 6/13/11 sent an 'URGENT MEDICAL DEVICE RECALL NOTIIFICATION" letter to all affected customers that included the device name, lot number, dates of distribution, reason for the recall, risks associated with use of the device, a photo of the device, instructions to quarantine and return the devices, and a form to fax back to the firm to confirm receipt and adherence to the recall letter.
- Quantity
- 95 Units
- Distribution
- Worldwide Distribution - USA including CA, LA,, MI, NJ, OH, OR, AR, IN, and Internationallly to Australia, Duisburg, Newbury and Hong Kong.
- Lot, serial or model codes
- Lot number 10265CG2, Part number 5290-744-100
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GFA
- Firm FEI
- 1811755
- Firm city
- Kalamazoo
- 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