The Recall Desk
ModerateFDA (Devices)·Z-2752-2016·Announced 2016-09-14

Zimmer Biomet Recalls Coonrad/Morrey Elbow Replacement Kits Due to Missing Parts

Zimmer Biomet is recalling a specific lot of Coonrad/Morrey Elbow Pin/Bushing Replacement Kits because they are missing a humeral bushing, which could delay surgery.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a voluntary precautionary recall for a packaging error (missing part) that results in surgical delay or additional surgery, fitting the criteria for moderate severity without reported injuries or deaths.

Plain-English summary

Zimmer Biomet, Inc. is conducting a voluntary recall of a single lot of the Coonrad/Morrey Elbow Pin/Bushing Replacement size Kit Extra Small. The recall is due to a packaging error where the kits were shipped with a missing humeral bushing. The affected product is a total elbow prosthesis designed for use with bone cement, sold sterile in a sealed package.

The missing component poses a risk of surgical delay or the need for additional surgery if a replacement part is not available during the procedure. The recall involves 25 units from Lot Number 62811341, Item Number 32-8105-027-01. These units were distributed worldwide, including to the United States (specifically AL, AZ, CA, CT, GA, MN, NC, OH, and OR) and internationally to Australia, Germany, Japan, Korea, and Taiwan.

Healthcare providers and facilities that have received this specific lot should stop using the affected kits and contact Zimmer Biomet for instructions on how to return the product or obtain replacements. Patients who have already had surgery using this specific lot should consult their surgeon if they have concerns about the integrity of their implant.

The recalled product

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 o
Affected units
25

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Item Number: 32-8105-027-01 Lot Number: 62811341

Distribution

Distributed in 9 states: