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 labele
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is voluntarily recalling a single lot of Modular Hybrid Glenoid Base Large components for the Comprehensive Shoulder System. Two pieces from lot number 270260 were shipped despite having an open defect report; one piece had scratches and the other had non-conforming threads. A total of 16 units from this lot were distributed worldwide, including to locations in the United States (Ohio, Arizona, Idaho, Pennsylvania, Arkansas, Minnesota, Illinois, California, Maryland, and New York) and Canada.
The recall affects Model Number 113956, Item Number 113956, Lot Number 270260, with UDI Number (01) 00880304462618 (17) 211204 (10) 270260. The product comes in an AlOx coated PET pouch and is vacuum sealed with an Argon flush. The source document does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Worldwide Distribution - US including OH AZ ID PA AR MN IL CA MD CA MN NY Foreign: Canada Quantity: 16 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.