Z-2601-2014Class II

CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic

Name: Z-2601-2014 CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Creator: Wright Medical Technology, Inc.
Published: 2014-07-30
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2014-07-30 / Terminated / root cause: design

FDA source

Wright Medical Technology, Inc. began a recall of CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic on 2014-07-30. FDA classified it as Class II and gives the reason as "Plates manufactured from an incorrect raw material". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2601-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-30
Posted: 2014-09-08
Terminated: 2018-06-15
Recalling firm: Wright Medical Technology Inc
Product: CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Product code: HRS Plate, Fixation, Bone
Reason for recall: Plates manufactured from an incorrect raw material.
Root cause tag: design
FDA root cause: Device Design
Action: Wright Medical sent an Urgent Medical Device Recall letter dated July 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product and immediately quarantine all affected product and return to Wright Medical as soon as possible. For return instructions customers were instructed to contact Customer Service at 800-238-7117. Customers were also asked to complete the attached response form, confirming receipt of the notice and the status of the product(s) on hand and return by fax to 901-867-7401. Customers with questions were instructed to call 901-290-5662. For questions regarding this recall call 800-238-7117.
Quantity in commerce: 497 units
Distribution: Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.
Product codes and lots: Lot Numbers: 1487673, 1487674, 1487675, 1487676, 1490003, 1512150, 1512151, 1519497, 1519498, 1522019, 1522020, 1523747, 1523748, 1537072, 1537073, 1537162, 1539399, 1541615, 1541616, 1543148, 1543149

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2601-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2599-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-08
Z-2600-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-08
Z-2601-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-08
Z-2602-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-08
Z-2603-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-08
Z-2604-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-08
Z-2605-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-08
Z-2607-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-08
Z-2608-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-08

Product code HRS

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)