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EXPLOR recallZ-0269-2018 · Zimmer Biomet, Inc. · initiated Jun 16, 2017

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Packaging change control

What the company is doing

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

Recall details

Recall number
Z-0269-2018
Status
Terminated
Initiated by the company
Jun 16, 2017
Recalling firm
Zimmer Biomet, Inc.
Product code
KWI
FDA submissions
K051385
Distribution
US, Canada, OUS.

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

14 devices cleared under K051385 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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