Z-2216-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2017
- Initiation Date
- April 26, 2017
- Termination Date
- March 30, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
Product Description
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
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US including OH AZ ID PA AR MN IL CA MD CA MN NY Foreign: Canada
Code Information
Model Number: 113956, Modular Hybrid Glenoid Base Large, Item Number: 113956, Lot Number: 270260, UDI Number: (01) 00880304462618 (17) 211204 (10) 270260