Z-0618-2011

Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet...

Name: Z-0618-2011 Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet...
Creator: Stryker Endoscopy
Published: 2009-08-20
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2009-08-20 / Terminated / root cause: manufacturing process

FDA source

Stryker Endoscopy began a recall of Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto... on 2009-08-20. The reason FDA records is "Potential breakage -- product may break while inserting it into the bone during surgery. This may prolong surgery, or, if undetected during surgery, result in retained fragments that may cause metal sensitization or...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0618-2011
Status: Terminated
Initiated: 2009-08-20
Posted: 2010-12-14
Terminated: 2010-12-14
Recalling firm: Stryker Corp.
Product: Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico
Product code: HWC Screw, Fixation, Bone
Reason for recall: Potential breakage -- product may break while inserting it into the bone during surgery. This may prolong surgery, or, if undetected during surgery, result in retained fragments that may cause metal sensitization or immune response, or necessitate further intervention to retrieve the titanium fragments.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Stryker issued an Urgent Device Removal notification letter dated August 21, 2009 to consignees. Consignees were asked to acknowledge receipt and distribute the letter, track reponses, and destroy any returned material and document through weekly summary and records. Stryker can be contacted at 408 754-2000 about this recall.
Quantity in commerce: 447 units
Distribution: Nationwide Distribution: to one distributor in NJ.
Product codes and lots: Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, serial numbers 09049AE2, 09050AE2, 09051AE2, 09052AE2, 09054AE4

Product code HWC

K071157Class IIStryker Peek and Titanium Soft Eyelet AnchorsStryker Endoscopy / cleared 2007-09-17

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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)