Stryker Tornier recalls 45% reversed inserts for shoulder surgery due to potential improper assembly causing safety risks. Affected units have specific batch numbers and model identifiers.
Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
Stryker Tornier is recalling a specific type of shoulder implant component because some units might be assembled incorrectly, which could cause the implant to not stay securely in place during surgery. This could lead to complications for patients receiving the procedure.
The reversed inserts may have a locking ring assembled upside down. This could prevent the humeral insert from securely seating in the stem or spacer during shoulder surgery, potentially causing the implant to dislodge.
Patients who received the Stryker Tornier Perform Humeral System, Reversed Insert, 45% (REF DWP2393) during shoulder surgery are likely affected. Surgeons and medical staff using this specific implant model are at higher risk if they have the affected batch.
Check for the model name 'Stryker Tornier Perform Humeral System, Reversed Insert, 45%' and the reference number DWP2393. Affected units also have the batch lot number 1495AY.
Review the product's batch lot number and reference code to confirm if it matches the affected units (DWP2393, batch 1495AY).
No, this recall specifically affects the Stryker Tornier Perform Humeral System, Reversed Insert, 45% with reference number DWP2393 and batch lot 1495AY.
The recall record does not specify a remedy or action for affected users, so contact the manufacturer directly for guidance.
Check for the model name 'Stryker Tornier Perform Humeral System, Reversed Insert, 45%' and reference number DWP2393 with batch lot 1495AY.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-3309-2024 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-3309-2024 from Tornier. 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.
