FDA Medical Device Recalls (openFDA)
Tornier, Inc: stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
- Recall number
- Z-0113-2024
- Recalling firm
- Tornier, Inc
- Product
- stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
- Status
- Open, Classified
- Initiated
- 2023-09-15
- Posted
- 2023-10-13
- Terminated
- not on file
- Reason
- One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.
- Root cause
- Process change control
- Action
- Stryker issued an URGENT MEDICAL DEVICE RECALL NOTICE to its consignees on 09/15/2023 by email and letter. The letter explained the issue and the risk. Actions requests were: Check inventory, quarantine, and respond to the notice. Distributors were directed to notify all applicable parties. Stryker is requesting the return of the affected product.
- Quantity
- 30 units
- Distribution
- US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN
- Lot, serial or model codes
- UDI/DI 10846832062017, Lot Number 1756123
- 510(k) numbers
- K161742
- PMA numbers
- not on file
- Product code
- PHX
- 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