FDA Device recall Z-0269-2018
ExploR Radial Head Replacement System
- FDA Device
- Class II
- terminated
- Published 2017-12-27
On 2017-12-27 the FDA classified a Class II recall of ExploR Radial Head Replacement System by Zimmer Biomet, citing 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 inc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0269-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-16 |
| Published | 2017-12-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | n/a |
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.
Reason
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.
Identifiers
| code_info | Part Lot UDI Number 11-210061 243610 and 202900; (01)00880304210448(17)260817(10)243610 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2020-11-11 · Zimmer Biomet
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0269-2018%22
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