—#198477

Product

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

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K113014
Affected lot / code info: GTIN 00840420110770, Lot Number 1636042

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Wright Medical Technology, Inc.
Address: 1023 Cherry Rd, Memphis, Tennessee 38117-5423

Distribution

Distribution pattern: US Nationwide distribution in the state of NY.

Timeline

Recall initiated: 2023-02-02
Posted by FDA: 2023-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198477. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.