CLASS II Device recall · Reported 27 May 2015 · FDA Enforcement Report

Phalinx (tm) Hammertoe Handle, Size: X-small, Style: Angled recalled

Wright Medical Technology is recalling Phalinx (tm) Hammertoe Handle, Size: X-small, Style: Angled, distributed nationwide in the US. The recall was initiated on 16 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 1344534
Quantity recalled126 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1624-2015
FDA event ID
71143
Recalling firm
Wright Medical Technology, Memphis, TN
Classification
Class II
Status
Terminated
Recall initiated
16 Apr 2015
FDA classified
18 May 2015
Reported
27 May 2015
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Other Reasons

Timeline

16 Apr 2015Recall initiated by company
18 May 2015Classified by FDA+32 days
27 May 2015Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is Phalinx (tm) Hammertoe Handle, Size: X-small, Style: Angled recalled?

Yes. Wright Medical Technology recalled Phalinx (tm) Hammertoe Handle, Size: X-small, Style: Angled on 16 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-1624-2015.

Why was it recalled?

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

Which lots are affected?

Lot 1344534

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Wright Medical Technology

All 78
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIstryker Infinity Resection Adjustment Block recalledWright Medical TechnologyOtherNE, TX
DeviceCLASS IIStryker Infinity Alignment Frame Distal Sub-Assembly recalledWright Medical TechnologySterilityTN
DeviceCLASS IIstryker Ortholoc 3Di Fusion Plate MTP Right recalledWright Medical TechnologyOtherNationwide
DeviceCLASS IIstryker Ortholoc 3Di Fusion Plate MTP Right recalledWright Medical TechnologyOtherNationwide
DeviceCLASS IIOrtholoc 3DSi Claw II 4 Hole Plate, Size recalledWright Medical TechnologyPackaging DefectsNationwide

Other Other Medical Devices recalls

All 13,771
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIMedline Convenience Kits: Blood Draw Kit recalled by Medline IndustriesMedline IndustriesSterilityNationwide
DeviceCLASS IIMedline Convenience Kits containing BD ChloraPrep Clear recalledMedline IndustriesLead & Heavy MetalsNationwide
DeviceCLASS IIMedline Convenience Kits: Ortho Aspiration Kit recalledMedline IndustriesSterilityNationwide
DeviceCLASS IIMedline Convenience Kits containing BD ChloraPrep DYKA1054F recalledMedline IndustriesLead & Heavy MetalsNationwide
DeviceCLASS IIMedline Convenience Kits: Arterial Line Insertion Kit recalledMedline IndustriesSterilityNationwide