FDA Medical Device Recalls (openFDA)
Tornier, Inc: Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
- Recall number
- Z-3309-2024
- Recalling firm
- Tornier, Inc
- Product
- Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
- Status
- Open, Classified
- Initiated
- 2024-08-29
- Posted
- 2024-09-27
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via email. The notice explained the issue, potential risk, and requested the following actions be taken: Identify and isolate the affected units, and respond to the notice via email. Upon receipt of the response, Stryker will arrange for the return of the device. Those consignees who further distributed the product (to other sites or customers) were directed to notify those parties. For questions or concerns, contact: memphis.fieldaction@stryker.com.
- Quantity
- 38 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- GTIN 00846832084494, Batch Lot # 1495AY
- 510(k) numbers
- ["K201315"]
- PMA numbers
- not on file
- Product code
- PAO
- Firm FEI
- 3000718467
- Firm city
- Bloomington
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28