PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 14, 2016 Initiated: August 16, 2016 #Z-2752-2016

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
25 units
Distribution
Worldwide Distribution - US including AL, AZ, CA, CT, GA, MN, NC, OH, OR and Internationally to Australia, Germany, Japan, Korea, and Taiwan.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Zimmer Biomet, Inc.. Units affected: 25 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 14, 2016. Severity: Moderate. Recall number: Z-2752-2016.

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