Z-1538-2008

Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145 Intended for use in...

Name: Z-1538-2008 Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145 Intended for use in...
Creator: Stryker Endoscopy
Published: 2008-02-07
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2008-02-07 / Terminated / root cause: packaging

FDA source

Stryker Endoscopy began a recall of Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145 Intended for use in securing soft tissue to bone in certain procedures in... on 2008-02-07. The reason FDA records is "Product package may crack and cause loss of sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1538-2008
Status: Terminated
Initiated: 2008-02-07
Posted: 2008-08-06
Terminated: 2010-12-21
Recalling firm: Stryker Corp.
Product: Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145 Intended for use in securing soft tissue to bone in certain procedures in specific areas.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Product package may crack and cause loss of sterility.
Root cause tag: packaging
FDA root cause: Packaging
Action: Stryker Endoscopy initiated the recall on 02/07/2008 by notifying its consignees via telephone, as well as sending out Urgent: Device Removal notices. Recipients of affected lots are to inspect their inventory for part/lot numbers and quarantine any affected product. Affected products are to be returned to Stryker Endoscopy and Customer Service should be contacted for replacement alternatives. Also, the "Acknowledgment of recipt" card needs to be signed and returned to Stryker Endoscopy.
Quantity in commerce: 53 units
Distribution: Product was distributed to 8 consignees in CA, OH, PA, CO, MA, and NJ.
Product codes and lots: Lot Numbers 07299AE2

Product code MBI

K983557Class IIStryker Wedge Suture AnchorStryker Endoscopy / cleared 1998-12-18

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)