ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces added to the top and bottom of the tray for protection. The inner tray and the contents within will then have a Tyvek lid heat sealed to the tray. The sealed inner tray will be fit into an outer PETG tray and a Tyvek lid heat sealed to the tray. The entire sealed unit is placed in a SBS carton that will be shrink wrapped for protection.
FDA Recall Z-0269-2018 · Posted None
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Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeKWI
Date Initiated2017-06-16
Date Terminated2018-09-06
Reason for Recall
Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular Radial HD lock screw was not included in the package for the stem.
Firm Action
Zimmer Biomet sent US Fiedl action notices 6/16/17 via email and fed Ex.
On 9/5/17, firm expanded their recall to include 1 lot and distributed Amended notices via email and FedEx
Root Cause
Packaging change control
Distribution Pattern
US, Canada, OUS.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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