Stryker Spine recalls specific lumbar intervertebral fusion instruments due to potential device failure during spinal surgery. Affected items include TL Inserter, Draw Rod, and Syringe Plunger components with UDI codes listed.
Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found non-conformances with the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger that could lead to device failure during a procedure.
Stryker Spine is recalling lumbar intervertebral fusion instruments that may fail during spinal surgery. This recall affects specific model components used in spinal fusion procedures with bone grafts.
The recalled instruments have non-conforming components that could fail during spinal surgery. This failure might lead to complications such as improper bone graft placement or surgical errors.
Patients undergoing lumbar spinal fusion surgery with bone grafts using the Tritanium X TL system are most at risk. Healthcare providers using these specific instruments for spinal procedures may also be affected.
Check for the specific UDI codes: 07613327366310, 07613327366839680220102, 07613327366884, or 07613327366457. The instruments include TL Inserter, Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger.
Look for the specific UDI codes listed in the recall: 07613327366310, 07613327366839680220102, 07613327366884, or 07613327366457.
Reach out to Stryker Spine directly for further instructions on handling the recalled instruments.
The recalled instruments have non-conforming components that could fail during spinal surgery, potentially causing improper bone graft placement or surgical errors.
The affected UDI codes are 07613327366310, 07613327366839680220102, 07613327366884, and 07613327366457.
The recall does not require immediate discontinuation; healthcare providers should check UDI codes and contact Stryker Spine for further instructions.
We’ve drafted a message you can send Stryker Spine to request your refund or repair — edit it as you like.
Subject: Recall Z-1437-2021 — Stryker Spine Stryker Spine Hello, I own a Stryker Spine that is covered by recall Z-1437-2021 from Stryker Spine. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
