CLASS II Device recall · Reported 27 Dec 2017 · FDA Enforcement Report
ExploR Radial Head Replacement System recalled by Zimmer Biomet
Zimmer Biomet is recalling ExploR Radial Head Replacement System. The recall was initiated on 16 Jun 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0269-2018
- FDA event ID
- 78705
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jun 2017
- FDA classified
- 20 Dec 2017
- Reported
- 27 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Masks, Gloves & PPE
Timeline
| 16 Jun 2017 | Recall initiated by company | |
| 20 Dec 2017 | Classified by FDA | +187 days |
| 27 Dec 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US, Canada, OUS.
Questions about this recall
Why was it 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.
Which lots are affected?
Part Lot UDI Number 11-210061 243610 and 202900; (01)00880304210448(17)260817(10)243610
Where was it sold?
US, Canada, OUS.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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