FDAClass IISeptember 19, 2018

Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm recall

Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180

Why was Affixus¿ Hip Fracture Nail 125¿ 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?

017090 017100 017110 017120 063130 063190 188050 188080 188090 219720 219730 219740 219750 290520 290550 331360 371020 371060 455870 455890 530040 530060 530080 541100 559250 559260 559270 559290 688160 706780 899800 944420 530030 530090

Product
Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180
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