SEASPINE recalls NorthStar OCT Navigation Surgical Technique Guide and instruments due to incorrect compatibility warnings with Medtronic systems. This could lead to improper use if the guide lists Infinity toolcards as compatible.
The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only.
SEASPINE is recalling its NorthStar OCT Navigation Surgical Technique Guide and instruments because the guide incorrectly lists Medtronic Infinity toolcards as compatible with the instruments. This could cause improper surgical use if the guide is followed without checking compatibility.
The NorthStar OCT Navigation Surgical Technique Guide incorrectly identifies Medtronic Infinity system toolcards as compatible with the instruments. The instruments are only compatible with Medtronic Solera toolcards. Using the wrong toolcards could lead to improper surgical procedures.
Surgical teams using the NorthStar OCT Navigation Surgical Technique Guide (STG) and instruments. Patients undergoing surgery with these devices are at risk if the guide is used incorrectly.
Check for the NorthStar OCT Navigation Surgical Technique Guide (STG) revisions D0003926A-D and instruments with reference numbers PC2-400012 to PC2-400355. The recall includes specific model numbers and lot codes listed in the record.
Review the product reference numbers and revisions listed in the recall notice to confirm if your items are affected.
The NorthStar OCT Navigation Surgical Technique Guide incorrectly lists Medtronic Infinity toolcards as compatible with the instruments, when they are only compatible with Medtronic Solera toolcards.
No, the recall does not require immediate discontinuation. However, you should verify compatibility before use.
Check the product reference numbers and revisions listed in the recall notice to confirm if your items are affected. If affected, ensure you use only Medtronic Solera toolcards.
We’ve drafted a message you can send SEASPINE ORTHOPEDICS to request your refund or repair — edit it as you like.
Subject: Recall Z-0937-2026 — SEASPINE ORTHOPEDICS SEASPINE ORTHOPEDICS Hello, I own a SEASPINE ORTHOPEDICS that is covered by recall Z-0937-2026 from SEASPINE ORTHOPEDICS. 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.
