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Recall Observatory FDA recall evidence

Device product

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

Z-1615-2014

April 22, 2014

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 68144
Status
Terminated
Classification
Class II
Quantity
8 devices
Official record key
device-enforcement:Z-1615-2014

Official wording

Reason: 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.

Code information: Catalog Number: 11-210062 Lot Number Identification: 972230

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.