—#167318

Product

Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product Usage: Intended for the fixation of fractures

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K100238
Affected lot / code info: Lot Numbers: 369380 436290

Why it was recalled

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Root cause (FDA determination)

Employee error

Action the firm took

Urgent Medical Device Recall notification letters dated 8/8/18 were sent to customers. The letters identified the affected products, problem and actions to be taken. Customers were instructed to: 1. Complete the Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 2. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were distributed to the following foreign countries: Chile, Netherlands.

Timeline

Recall initiated: 2018-08-08
Terminated: 2020-07-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167318. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.