Z-1108-2010

ACM Bio-Prep with Merocel pkg/6, Rx, Sterile, REF 0306-708-000S4, Stryker Instruments, Kalamazoo, MI. The...

Name: Z-1108-2010 ACM Bio-Prep with Merocel pkg/6, Rx, Sterile, REF 0306-708-000S4, Stryker Instruments, Kalamazoo, MI. The...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2010-01-25
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2010-01-25 / Terminated / root cause: labeling and UDI

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of ACM Bio-Prep with Merocel pkg/6, Rx, Sterile, REF 0306-708-000S4, Stryker Instruments, Kalamazoo, MI. The femoral sponge is an absorbent that is used to dry... on 2010-01-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1108-2010
Status: Terminated
Initiated: 2010-01-25
Posted: 2010-03-15
Terminated: 2010-10-25
Recalling firm: Stryker Corp.
Product: ACM Bio-Prep with Merocel pkg/6, Rx, Sterile, REF 0306-708-000S4, 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.
Product code: GDY Gauze/Sponge, Internal, X-Ray Detectable
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: 05257012 and 08129012.

Product code GDY

K955599Class IStryker Femoral Canal Sponge & Acetabulum SpongeStryker Corp. / cleared 1996-02-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)