—#127000

Product

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

FDA product code: KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K040611, K051385
Affected lot / code info: Catalog Number: 11-210062 Lot Number Identification: 972230

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

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

Timeline

Recall initiated: 2014-04-22
Posted by FDA: 2014-05-13
Terminated: 2015-01-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127000. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.