—#178851

Product

Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.

FDA product code: JDC — Prosthesis, Elbow, Constrained, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K001989
Affected lot / code info: Lot 64481139

Why it was recalled

The lot contained two outer pins instead of one outer and one inner pin.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On December 12, 2019, the firm distributed Urgent Medical Device Recall letters to affected customers. The letter alerted customers that the product was potentially packaged with two outer pins and zero inner pins. Customer responsibilities: 1. Review the notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete the included Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Distributed to accounts in California and Ohio.

Timeline

Recall initiated: 2019-12-12
Terminated: 2021-01-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178851. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.