FDAClass IISeptember 19, 2018

Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm recall

Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm, Item Number: 814513400

Why was Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm recalled?

The set screw is not able to advance or reverse from the original position in the nail.

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?

152980 482780 530160 798520 798530 798540 773050

Product
Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm, Item Number: 814513400
Recalling firm
Zimmer Biomet, Inc.
Quantity
5947 total
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 countries: Chile, Ecuador, Japan, Netherlands.
Recall date
September 19, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls