Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0269-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 16, 2017

Date Posted: December 27, 2017

Recall Number: Z-0269-2018

Event ID: 78705

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.

Status: Terminated

Product Quantity:

Code Information:

Part Lot UDI Number 11-210061 243610 and 202900; (01)00880304210448(17)260817(10)243610

Distribution Pattern:

US, Canada, OUS.

Voluntary or Mandated:

Voluntary: Firm initiated