Z-1170-2023Class II

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

Name: Z-1170-2023 ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
Creator: Wright Medical Technology, Inc.
Published: 2023-02-02
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2023-02-02 / Open, Classified / root cause: manufacturing process

FDA source

Wright Medical Technology, Inc. began a recall of ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device on 2023-02-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1170-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-02
Posted: 2023-02-24
Recalling firm: Wright Medical Technology Inc
Product: ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
Product code: HRS Plate, Fixation, Bone
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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 [email protected] 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.
Quantity in commerce: 4 units
Distribution: US Nationwide distribution in the state of NY.
Product codes and lots: GTIN 00840420110770, Lot Number 1636042

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1170-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1169-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-24
Z-1170-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-24

Product code HRS

K113014Class IIClaw II Polyaxial Compression System and Ortholoc 3Dsi Locking ScrewsWrightmedicaltechnologyinc / cleared 2012-01-31

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)