FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: ACM with Femoral Brush and Femoral Sponge, Rx, Sterile, REF 306-705-000S8, Stryker Instruments, Kalamazoo, MI. The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction.
- Recall number
- Z-1107-2010
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- ACM with Femoral Brush and Femoral Sponge, Rx, Sterile, REF 306-705-000S8, Stryker Instruments, Kalamazoo, MI. The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction.
- Status
- Terminated
- Initiated
- 2010-01-25
- Posted
- 2010-03-15
- Terminated
- 2010-10-25
- Reason
- The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product.
- Root cause
- Other
- Action
- A "Medical Device Recall Notification" dated January 21, 2010 was issued to customers. The notification described the affected product, issue and actions to take. Consignees were asked to forward the notification to all their affected locations. Customers were instructed to immediately check inventory and quarantine any recalled product found. Consignees were instructed to destroy all product and report how much product was destroyed. For questions regarding this recall, please contact Stryker Instruments by calling 1-800-800-4236, ext. 4354
- Quantity
- 9,274 all products
- Distribution
- Worldwide Distribution -- United States, Canada, Mexico, Australia, Brazil, Switzerland, Japan, Netherlands, England, UK, Sweden, Hong Kong, Korea, Malaysia, Singapore, Argentina, Spain, and Italy.
- Lot, serial or model codes
- 05068CS2 and 05210012.
- 510(k) numbers
- ["K955599"]
- PMA numbers
- not on file
- Product code
- GDY
- 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