Product Wiki · Recalls · U.S. FDA — Device Enforcement

Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 420 mm, Item Number… — recall Z-3151-2018

U.S. FDA — Device Enforcement · United States · 2018-07-17 · Class II

As described by U.S. FDA — Device Enforcement: Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 420 mm, Item Number: 814609420

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3151-2018
Date of alert
2018-07-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Biomet, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign co
Barcode (EAN/GTIN)
814609420
Reported risk: The set screw is not able to advance or reverse from the original position in the nail.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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