Z-2223-2014Class II

Vl DBL OFFST WI LRG STPL, RT Nonsterile

Name: Z-2223-2014 Vl DBL OFFST WI LRG STPL, RT Nonsterile
Creator: Zimmer, Inc.
Published: 2014-07-23
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-07-23 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of Vl DBL OFFST WI LRG STPL, RT Nonsterile on 2014-07-23. FDA classified it as Class II and gives the reason as "The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2223-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-23
Posted: 2014-08-14
Terminated: 2015-09-15
Recalling firm: Zimmer GmbH
Product: Vl DBL OFFST WI LRG STPL, RT Nonsterile
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
Root cause tag: design
FDA root cause: Device Design
Action: On July 23, 2014, Zimmer issued recall notification to their consignees. Distributors were notified via electronic mail and courier. Recall notification included a description of the issue, affected product, possible risks to patient, and instructions for responding to the recall. Questions or concerns regarding the recall are directed to Zimmer customer call center @ 1-800-348-2759 M-F, 8am-8pm ET.
Quantity in commerce: 412 units
Distribution: Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.
Product codes and lots: Item Number 82016757942 Lot Number 97009220, 97009255, 97009256, 97009585

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2223-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2216-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2217-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2218-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2219-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2220-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2221-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2222-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2223-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2224-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2225-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2226-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2227-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2228-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2229-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2230-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14
Z-2231-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14

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)