Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 Product Usage: Intended for the fixation of fractures
FDA Recall Z-0136-2019 · Posted None
Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2018-08-08
Date Terminated2020-07-30
Product Quantity20
Reason for Recall
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Firm Action
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 [email protected]. 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 [email protected]
Root Cause
Employee error
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.