Use caution Medical device recall · FDA · Published August 29, 2024

Torn: Stryker Tornier Perform Humeral System Reversed Insert Recall for Shoulder Surgery

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3309-2024Medical device Tornier ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmTornier, Inc10801 Nesbitt Ave S · Bloomington, MN 55437-3109

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/54152-torn-stryker-tornier-perform-humeral-system-reversed-insert-recall-for.

Source Summary by GovInfoNow · govinfonow.com/recall/54152-torn-stryker-tornier-perform-humeral-system-reversed-insert-recall-for · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3309-2024

Cite this page

“Torn: Stryker Tornier Perform Humeral System Reversed Insert Recall for Shoulder Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54152-torn-stryker-tornier-perform-humeral-system-reversed-insert-recall-for. Based on FDA recall #Z-3309-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3309-2024%22&limit=1).

The FDA announced on 2024-08-29 that Tornier, Inc. is recalling Stryker Tornier Perform Humeral System Reversed Inserts for shoulder arthroplasty because a locking ring may be assembled upside down. This defect could prevent the humeral insert from securely seating in the stem or spacer.

How to tell if you have it

Brand: Tornier
Product: Stryker Tornier Perform Humeral System, Reversed Insert, 45%
REF: DWP2393
UPC: 00846832084494
Lot Code: 1495AY
Quantity: 38 units

The hazard

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.

Context

GovInfoNow's records show Tornier, Inc. has 12 other recalls on record since 2018-02-08. Recent examples include a 2026-03-05 recall for incompatible parts and a 2025-12-19 recall involving incorrect labeling of screws. Other recent recalls of similar products include Encore Medical RSP Humeral Socket Insert Recall (2026-01-15), Zimmer Off-Axis Shoulder System Recall (2026-05-20), and Zimmer Off-Axis Shoulder System Recalled Due to Plastic Guide Breakage (2026-05-20).

How to tell if you have this one

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.

Brand
Tornier
Product
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Review the product's batch lot number and reference code to confirm if it matches the affected units (DWP2393, batch 1495AY).

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 41 days after the firm started it.

Aug 29, 2024Firm started the recall
Sep 27, 2024FDA classified it Class II
Oct 9, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/54152-torn-stryker-tornier-perform-humeral-system-reversed-insert-recall-for">Torn: Stryker Tornier Perform Humeral System Reversed Insert Recall for Shoulder Surgery (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-3309-2024 (August 29, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3309-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.