Recall Z-0269-2018 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Zimmer Biomet, Inc.
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
| Date | Jun 16, 2017 |
| Status | Terminated |
| 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051385 | EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE Biomet, Inc., Aug 5, 2005 |