Device recall: PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY

Class II FDA enforcement event 71143. Recall start date: 16 Apr 2015. Status in the FDA record: Terminated. Termination date: 18 Oct 2018.

Reason for recall, in the words of FDA

The term DORSAL was laser etched on the incorrect side on some of the angled handles.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Wright Medical Technology, Inc. started this device recall on 16 Apr 2015. The firm address in the FDA record is in Memphis, TN. FDA put the recall in Class II. FDA event 71143 has 4 product records. The first FDA enforcement report date is 27 May 2015. The record gives the status Terminated, with the termination date 18 Oct 2018.

FDA enforcement report The 4 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution

Recalling firm

Wright Medical Technology, Inc., Memphis, TN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

4 product records in the event.

FDA event 71143: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1624-2015	PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY	126 units	Class II	Terminated	27 May 2015
Z-1625-2015	PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONTENTS 1 EACH, RX ONLY	121 units	Class II	Terminated	27 May 2015
Z-1626-2015	PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY	124 units	Class II	Terminated	27 May 2015
Z-1627-2015	PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY	126 units	Class II	Terminated	27 May 2015

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2015: 1,153
Share of these events in Class II: 91%
Product records in this event: 4Median of the firm: 2
Events of the firm on the register: 26

Other events of the firm

Other FDA enforcement events of Wright Medical Technology, Inc.
Initiated	Product (first record)	Type	Class	Records
6 Mar 2024	stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty	Device	Class II	1
13 Jun 2023	Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.	Device	Class II	1
10 Apr 2023	stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation	Device	Class II	2
2 Feb 2023	ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device	Device	Class II	2
30 Sep 2022	Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3	Device	Class II	2
3 Aug 2022	stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair	Device	Class II	2
27 Jul 2022	Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.	Device	Class II	1
14 Jun 2022	Wright EVOLVE TRIAD Plate Cutter, REF 49510120	Device	Class II	1
2 Jun 2022	Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINI	Device	Class II	1
10 Mar 2022	EasyFuse Dynamic Compression System Instrument Pack	Device	Class II	1

Wright Medical Technology, Inc.: all 26 events

Official channels

FDA enforcement report Z-1624-2015The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 71143. https://recallregister.com/fda/ii/71143/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution
What quantity of product is in FDA event 71143?: The event has 4 product records. The first record gives this quantity: 126 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.