Stryker Titanium Intraline Anchor, Model Numbers… recallZ-0618-2011 · Stryker Endoscopy · initiated Aug 20, 2009
Terminated All recalls posted in December 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Endoscopy or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Material/Component Contamination
What the company is doing
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.
Recall details
- Recall number
- Z-0618-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 20, 2009
- Posted by the FDA
- Dec 14, 2010
- Recalling firm
- Stryker Endoscopy
- Quantity
- 447 units
- Product code
- HWC
- FDA submissions
- K071157
- Distribution
- Nationwide Distribution: to one distributor in NJ.
Product description
Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico
Code information (models, lots, serial numbers)
Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, serial numbers 09049AE2, 09050AE2, 09051AE2, 09052AE2, 09054AE4
Other devices under the same FDA submission
4 devices cleared under K071157 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PEEK IntraLine 3910-400-010Stryker Corporation · Screw, fixation, bone21 reports
- PEEK IntraLine 3910-400-015Stryker Corporation · Screw, fixation, bone6 reports
- Titanium IntraLine 3910-400-055Stryker Corporation · Screw, fixation, bone3 reports
- Titanium IntraLine 3910-400-050Stryker Corporation · Screw, fixation, bone3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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