Recalls / —
—#160165
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.
- FDA product code
- KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K051385
- Affected lot / code info
- Part Lot UDI Number 11-210061 243610 and 202900; (01)00880304210448(17)260817(10)243610
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.
Root cause (FDA determination)
Packaging change control
Action the firm took
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
Recalling firm
- Firm
- Zimmer Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- Distribution pattern
- US, Canada, OUS.
Timeline
- Recall initiated
- 2017-06-16
- Terminated
- 2018-09-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #160165. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.