Stryker Peek Intraline Anchor, 6.5 mm, Model number… recallZ-1535-2008 · Stryker Endoscopy · initiated Feb 7, 2008
Terminated All recalls posted in August 2008
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
Product package may crack and cause loss of sterility.
FDA root cause category: Packaging
What the company is doing
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.
Recall details
- Recall number
- Z-1535-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 7, 2008
- Posted by the FDA
- Aug 6, 2008
- Recalling firm
- Stryker Endoscopy
- Quantity
- 146 units
- Product code
- HWC
- FDA submissions
- K071157
- Distribution
- Product was distributed to 8 consignees in CA, OH, PA, CO, MA, and NJ.
Product description
Stryker Peek Intraline Anchor, 6.5 mm, Model number 3910-400-020 Used for tissue fixation to bone in certain areas.
Code information (models, lots, serial numbers)
Lot numbers 07276AE2, 07299AE2, 07311AE2
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
Other products in the same recall event
The FDA groups related products into one recall event (event 46916).
- Z-1533-2008 · TerminatedStryker Peek Intraline Anchor, 5.5 mm, Model number 3910-400-010 Used for tissue fixation to bone in certain areas.
- Z-1534-2008 · TerminatedStryker Peek Intraline Anchor, 5.5 mm with Needles, Model number 3910-400-015 Used for tissue fixation to bone in certain areas.
- Z-1536-2008 · TerminatedStryker Peek Intraline Anchor, 6.5 mm with Needles, Model number 3910-400-025 Used for tissue fixation to bone in certain areas.
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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