Modular Hybrid Glenoid Base Large for the Comprehensive recall
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…
Why was Modular Hybrid Glenoid Base Large for the Comprehensive 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 113956, Modular Hybrid Glenoid Base Large, Item Number: 113956, Lot Number: 270260, UDI Number: (01) 00880304462618 (17) 211204 (10) 270260
- 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…
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 16
- Distribution
- Worldwide Distribution - US including OH AZ ID PA AR MN IL CA MD CA MN NY Foreign: Canada
- Recall date
- June 7, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)