Z-2752-2016Class II

Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts...

Name: Z-2752-2016 Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts...
Creator: Zimmer Biomet, Inc.
Published: 2016-08-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-08-16 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of 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... on 2016-08-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2752-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-16
Posted: 2016-09-08
Terminated: 2017-06-12
Recalling firm: Zimmer GmbH
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
Product code: JDC Prosthesis, Elbow, Constrained, Cemented
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Zimmer Biomet sent an Urgent Medical Device Recall Removal letter dated August 16, 2016, for their C/M Elbow Pin/ Bushing Replacement Kit via FedEx. All distributors were notified via electronic mail. Hospital risk managers, as well as distributors with product, were notified via courier. Customers were instructed to complete the following items including locating and removing the product in their territory, as well as identifying hospitals that currently have the affected product. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers were provided with a letter identifying the issue and their responsibilities. These responsibilities include: - Assisting the Zimmer Biomet sales representative with the quarantine of the product and completion and return of the Attachment 1 form. - Complete and return Attachment 1 (Acknowledgement of Responsibility) to the fax number or email address provided. If there are questions or concerns please call the customer call center at 1-800-348-9500 ext 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to [email protected]. For questions regarding this recall call 877-946-2761.
Quantity in commerce: 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.
Product codes and lots: Item Number: 32-8105-027-01 Lot Number: 62811341

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2752-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2752-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08

Product code JDC

K001989Class IICoonrad/morrey Total Elbow. Model 32-8105 SeriesZimmer, Inc. / cleared 2000-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)