Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.

FDA device recall Z-0773-2024 · posted 2024-01-19 · Open, Classified

Recall details

Recalling firm

Tornier, Inc

Reason for recall

The incorrect device is contained in the labeled package.

Action taken

The recalling firm issued letters dated 1/3/2024 via email to sales representatives and distributors and via FedEx to hospitals on 1/3/2024. The letter provided a product description, product issue, potential risks including a photo of the device that should be in the package and a photo of the device that was in the package. The customer actions needed included: (1) Immediately check the inventory for the affected product, remove it from the point of use, and isolate/quarantine it to prevent accidental use; (2) Sign and return the enclosed Business Reply Form by email to confirm receipt of the notification; (3) Upon receipt of the completed Business Reply Form, the firm will contact the customer to arrange for return of the product; (4) If the product has been further distributed, notify the applicable parties at once about the recall. If possible, inform the recalling firm if any of the devices have been distributed to other organizations, including contact details. If the letter recipient is a distributor, they are responsible for notifying their affected customers.

Root cause

Packaging process control

Status

Open, Classified

Product code

PHX

Quantity affected

50

Distribution

Distribution was made to AR, AZ, CA, CO, CT, NC, OH, TN, and VA. There was no military/government distribution. Foreign distribution was made to Australia, France, and Italy.

Date initiated

2024-01-03

Date posted

2024-01-19

Location

Bloomington, MN

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