Z-1471-2018Class II

Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number...

Name: Z-1471-2018 Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number...
Creator: Zimmer Biomet, Inc.
Published: 2018-03-26
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-03-26 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00 on 2018-03-26. FDA classified it as Class II and gives the reason as "Potential failure of sterile packaging seal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1471-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-26
Posted: 2018-04-20
Terminated: 2020-11-18
Recalling firm: Zimmer GmbH
Product: Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Potential failure of sterile packaging seal.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy. All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018. " Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory. " Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter. " Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form. o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.
Quantity in commerce: 19483 total products
Distribution: US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
Product codes and lots: Lot Numbers: 63655999 63715685 63731170 63733045 63812299

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1471-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1465-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20
Z-1466-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20
Z-1467-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20
Z-1468-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20
Z-1469-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20
Z-1470-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20
Z-1471-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20
Z-1472-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20
Z-1473-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20
Z-1474-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20
Z-1475-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20
Z-1476-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20

Product code LXH

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

MDM coverage of this record lists here, newest first.

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)