Central Screw 6.5x25mm - Product Usage: used as a recall
Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
Why was Central Screw 6.5x25mm - Product Usage: used as a recalled?
Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
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 No.: 115395, Lot No.: 077170, UDI: (01) 00880304677074 (17) 301010 (10) 077170
- Product
- Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
- Recalling firm
- Biomet, Inc.
- Quantity
- 49
- Distribution
- US Nationwide distribution including in the states of MS, MN, KY, FL, MI, OH, AZ, IL, WI, CA, UT, TN.
- Recall date
- February 24, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)