Z-0542-2019Class II

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

Name: Z-0542-2019 Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number...
Creator: Zimmer Biomet, Inc.
Published: 2018-10-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-10-22 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use... on 2018-10-22. FDA classified it as Class II and gives the reason as "Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility". 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-0542-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-22
Posted: 2018-11-30
Terminated: 2020-12-30
Recalling firm: Zimmer GmbH
Product: Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Zimmer Biomet conducted recall to distributors and hospital risk managers on 10/22/18, distributors notified via email. Hospital risk managers, as well as distributors with product, will be notified via Fed'X." Distributors responsibilities include:- Locating and removing the product in their territory, as well as identifying hospitals with fielded inventory. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are 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: Ensuring affected personnel are aware of the notice contents - Assisting the Zimmer Biomet sales representative with the quarantine of the affected products. Certificate of Acknowledgement complete and send to [email protected]. This form must be returned even if you do not have affected products at your facility. Questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday
Quantity in commerce: 1676
Distribution: Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN
Product codes and lots: All lots expiring prior to September 30, 2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0542-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0530-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0531-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0532-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0533-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0534-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0535-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0536-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0537-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0538-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0539-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0540-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0541-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0542-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)