FDAClass IISeptember 19, 2018

Affixus¿ Hip Fracture Nail 130¿ 11 mm x 180 mm recall

Affixus¿ Hip Fracture Nail 130¿ 11 mm x 180 mm, Item Number: 814511180

Why was Affixus¿ Hip Fracture Nail 130¿ 11 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?

072620 130760 130770 130780 130790 130800 130810 130820 130840 130850 130860 130900 130920 131030 156770 157000 188340 219800 219810 219820 219910 245570 245690 287090 287120 287130 371170 456160 519490 530110 530120 530130 558980 565870 565880 601390 707920 768050 772730 854270 901300 901330 901350 901360 901370 901380 901400 901410 944660 944720 970790 970810 970820 970830 970840 970850 970860 970870 970880 970890 130930 130940 156970 503980 503990 504000 504010

Product
Affixus¿ Hip Fracture Nail 130¿ 11 mm x 180 mm, Item Number: 814511180
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