Z-2752-2016 Class II Terminated
FDA device recall Z-2752-2016 was initiated by Zimmer Biomet, Inc. on Aug 16, 2016 and is designated Class II. 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… The recall status is terminated (terminated Jun 12, 2017). Affected quantity: 25 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 14, 2016
- Initiation Date
- Aug 16, 2016
- Termination Date
- Jun 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 units
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.
Distribution Pattern
Worldwide Distribution - US including AL, AZ, CA, CT, GA, MN, NC, OH, OR and Internationally to Australia, Germany, Japan, Korea, and Taiwan.
Code Information
Item Number: 32-8105-027-01 Lot Number: 62811341
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2752-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026