RecallRadar

FDA Device recall Z-1471-2018

Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter

On 2018-05-02 the FDA classified a Class II recall of Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter by Zimmer Biomet, citing potential failure of sterile packaging seal.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1471-2018
ClassificationClass II
Statusterminated
Initiated2018-03-26
Published2018-05-02
Last updated2026-09-13 11:54 UTC
CompanyZimmer Biomet
DistributionUS

Product

Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00

Reason

Potential failure of sterile packaging seal.

Identifiers

code_infoLot Numbers: 63655999 63715685 63731170 63733045 63812299

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-1471-2018%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.