Z-1627-2015Class II

Phalinx (Tm) Hammertoe Handle, Size: Large, Style: Angled, Ref 45304014, Contents 1 Each, Rx Only

Name: Z-1627-2015 Phalinx (Tm) Hammertoe Handle, Size: Large, Style: Angled, Ref 45304014, Contents 1 Each, Rx Only
Creator: Wright Medical Technology, Inc.
Published: 2015-04-16
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2015-04-16 / Terminated / root cause: manufacturing process

FDA source

Wright Medical Technology, Inc. began a recall of PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY on 2015-04-16. FDA classified it as Class II and gives the reason as "The term DORSAL was laser etched on the incorrect side on some of the angled handles". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1627-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-16
Posted: 2015-05-18
Terminated: 2018-10-18
Recalling firm: Wright Medical Technology Inc
Product: Phalinx (Tm) Hammertoe Handle, Size: Large, Style: Angled, Ref 45304014, Contents 1 Each, Rx Only
Product code: HWC Screw, Fixation, Bone
Reason for recall: The term DORSAL was laser etched on the incorrect side on some of the angled handles.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Wright sent an Urgent Medical Device Recall letter dated April 13, 2015, 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, send it back to Wright Medical as soon as possible. Contact Customers Service at 901-867-4575 for return instructions and replacement inventory. Customers were instructed to complete the attached response immediately, confirming their receipt of this notice and the status of any product(s) on had, and return a copy by email to [email protected] or fax to 901-867-7401. Customers with questions should call 901-451-6144.
Quantity in commerce: 126 units
Distribution: Nationwide Distribution
Product codes and lots: Lot 1344534

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1627-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1624-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-18
Z-1625-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-18
Z-1626-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-18
Z-1627-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-18

Product code HWC

The FDA recall record names no cleared device, and no clearance has been matched to it.

China's FDA-registered implant bench is 151 establishments of 4,70415 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)