ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device

FDA device recall Z-1170-2023 · posted 2023-02-24 · Open, Classified

Recall details

Recalling firm

Wright Medical Technology, Inc.

Reason for recall

Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.

Action taken

The firm issued an URGENT MEDICAL DEVICE notice to its the sole consignee by email on 02/02/2023. The notice explained the product and the issue and requested the following actions be taken: 1. Check inventory for affected product and remove from use 2, Sign and return the enclosed Business Reply Form by email to fieldaction@stryker.com to confirm receipt of this notification/documenting product disposition. Stryker will will contact you to arrange for the return of the affected device(s) 3. Maintain awareness of this communication internally until all required actions have been completed within your facility.. 4. If you have further distributed the affected product, please notify the applicable parties at once about this recall. You may copy and distribute this notification letter. a. If possible, inform us if any of the subject devices have been distributed to other organizations, including contact details so that we can inform the recipients appropriately. b. If you are a distributor, note that you are responsible for notifying your affected customers.

Root cause

Employee error

Status

Open, Classified

Product code

HRS

Quantity affected

4 units

Distribution

US Nationwide distribution in the state of NY.

Date initiated

2023-02-02

Date posted

2023-02-24

Location

Memphis, TN

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