Z-0269-2018Class II

ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane...

Name: Z-0269-2018 ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane...
Creator: Zimmer Biomet, Inc.
Published: 2017-06-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-06-16 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of 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... on 2017-06-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0269-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-16
Posted: 2017-12-20
Terminated: 2018-09-06
Recalling firm: Zimmer GmbH
Product: 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 code: KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
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.
Root cause tag: packaging
FDA root cause: Packaging change control
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
Distribution: US, Canada, OUS.
Product codes and lots: Part Lot UDI Number 11-210061 243610 and 202900; (01)00880304210448(17)260817(10)243610

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0269-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0269-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-20

Product code KWI

K051385Class IIExplor Modular Radial Head Replacement DeviceBiomet, Inc. / cleared 2005-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)