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Recall Observatory FDA recall evidence

Device product

Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity is then placed into an outer cavity and heat sealed with outer Tyvek lid on the outer cavity. The patient record label is placed on the Tyvek outerlid. The sealed cavities and package insert is placed into a folding carton, sealed and shrink wrapped. Total elbow prosthesis designed for use with bone cement

Z-2752-2016

August 16, 2016

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 74930
Status
Terminated
Classification
Class II
Quantity
25 units
Official record key
device-enforcement:Z-2752-2016

Official wording

Reason: Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a missing humeral bushing. The missing bushing could result in a surgical delay or additional surgery if a replacement is not available.

Code information: Item Number: 32-8105-027-01 Lot Number: 62811341

Distribution pattern: Worldwide Distribution - US including AL, AZ, CA, CT, GA, MN, NC, OH, OR and Internationally to Australia, Germany, Japan, Korea, and Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a missing humeral bushing. The missing bushing could result in a surgical delay or additional surgery if a replacement is not available.