FDAClass IISeptember 19, 2018

Affixus¿ Hip Fracture Nail 130¿ 9 mm x 180 mm recall

Affixus¿ Hip Fracture Nail 130¿ 9 mm x 180 mm, Item Number: 814509180

Why was Affixus¿ Hip Fracture Nail 130¿ 9 mm x 180 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?

054130 085710 144520 150790 156740 156750 219790 245740 245820 287290 287400 456140 482650 707780 900280 944590 944630 944640 970640 609640 609650

Product
Affixus¿ Hip Fracture Nail 130¿ 9 mm x 180 mm, Item Number: 814509180
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