Z-1615-2014Class II

ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant

Name: Z-1615-2014 ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant
Creator: Biomet, Inc.
Published: 2014-04-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-04-22 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant on 2014-04-22. FDA classified it as Class II and gives the reason as "This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1615-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-22
Posted: 2014-05-13
Terminated: 2015-01-13
Recalling firm: Zimmer GmbH
Product: ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Product code: KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Reason for recall: This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Biomet sent an URGENT MEDICAL DEVICE SAFETY ALERT dated April 22, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in commerce: 8 devices
Distribution: US Nationwide Distribution in the states of NY, MD, NC, SC, MI, OR, and NV.
Product codes and lots: Catalog Number: 11-210062 Lot Number Identification: 972230

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1615-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1615-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-13

Product code KWI

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)