—#155038

Product

Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched product is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The labels also include a sterilization indication dot. This system is intended for primary and revision total shoulder arthroplasty, as well as hemi-arthroplasty

FDA product code: KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K060694
Affected lot / code info: Model Number: 113956, Modular Hybrid Glenoid Base Large, Item Number: 113956, Lot Number: 270260, UDI Number: (01) 00880304462618 (17) 211204 (10) 270260

Why it was recalled

Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the other non-confirming threads.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Zimmer Biomet initiated a voluntary recall on April 26, 2017, for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the other non-conforming threads. Notices were distributed via FedEx to customers. Risk Managers were instructed as follows: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1 Certificate of Acknowledgement. a. Return a digital copy within three (3) to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call 411 Technical Services at 574- 371-3071 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 corporatequality.postmarket@zimmerbiomet.com. Surgeons were instructed as follows: Review the notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this field action that are recommended beyond your existing follow up schedule. 3. Complete Attachment 1 Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a co

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Worldwide Distribution - US including OH AZ ID PA AR MN IL CA MD CA MN NY Foreign: Canada

Timeline

Recall initiated: 2017-04-26
Terminated: 2018-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155038. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.