RecallRadar

FDA Device recall Z-1465-2018

M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only

On 2018-05-02 the FDA classified a Class II recall of M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only by Zimmer Biomet, citing potential failure of sterile packaging seal.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1465-2018
ClassificationClass II
Statusterminated
Initiated2018-03-26
Published2018-05-02
Last updated2026-09-13 11:54 UTC
CompanyZimmer Biomet
DistributionUS

Product

M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00

Reason

Potential failure of sterile packaging seal.

Identifiers

code_infoLot Numbers: 63733049 63738623 63748399 63753770 63758430 63849380 77006555 77006556 77006557

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1465-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.