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Terminated

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

FDA Recall Z-1615-2014 · Posted 2014-05-13

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeKWI
Date Initiated2014-04-22
Date Terminated2015-01-13
Product Quantity8 devices

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide Distribution in the states of NY, MD, NC, SC, MI, OR, and NV.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051385EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICEBiomet, Inc. · 2005-08-05K040611MODULAR RADIAL HEAD REPLACEMENT DEVICEBiomet, Inc. · 2004-06-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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