Zimmer Biomet Affixus Hip Fracture Nail Recall: Set Screw Malfunction
Zimmer Biomet recalls Affixus Hip Fract: Set screw cannot advance or reverse, potentially causing improper fracture stabilization.
Lower-risk recall
The set screw is not able to advance or reverse from the original position in the nail.
Contact the company
What happened, in plain English
Zimmer Biomet is recalling hip fracture nails that have a set screw which won't move properly. This could lead to improper fracture stabilization during surgery, risking complications for patients. Read more at govinfonow.com/recall/69674-zimmer-biomet-affixus-hip-fracture-nail-recall-set-screw-malfunction.
Source Summary by GovInfoNow · govinfonow.com/recall/69674-zimmer-biomet-affixus-hip-fracture-nail-recall-set-screw-malfunction · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0452-2019
Cite this page
“Zimmer Biomet Affixus Hip Fracture Nail Recall: Set Screw Malfunction.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69674-zimmer-biomet-affixus-hip-fracture-nail-recall-set-screw-malfunction. Based on FDA recall #Z-0452-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0452-2019%22&limit=1).
Why it’s dangerous
The set screw in the nail cannot advance or reverse from its original position. This means the nail may not stabilize the hip fracture correctly during surgery, potentially leading to complications.
Who’s affected
Surgeons who use the Affixus Hip Fracture Nail System (item number 816712165) for hip fracture repairs are affected. Patients undergoing surgery with this specific nail system are at risk of improper stabilization.
How to tell if you have this one
Check for the Affixus Hip Fracture Nail System with item number 816712165. Lot numbers 145060, 901680, and 901690 are also associated with this recall.
- Brand
Zimmer Biomet- Category
Medical device
All 8 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and foreign countries of: Chile, Costa Rica, Ecuador and Netherlands.
| Recall number | Product, codes & lots |
|---|---|
| Z-0447-2019 | Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.; Lot number 371540 |
| Z-0448-2019 | Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.; Lot number 133240 971270 |
| Z-0449-2019 | Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.; Lot number 157410 171840 |
| Z-0450-2019 | Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.; Lot number 063610 063630 816520 |
| Z-0451-2019 | Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.; Lot number 945090 945230 |
| Z-0452-2019 | Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.; Lot number 145060 901680 901690 |
| Z-0453-2019 | Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.; Lot number 558260 558270 |
| Z-0454-2019 | Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.; Lot number 901770 |
What to do — step by step
Check Product Details
Verify the item number and lot numbers to confirm if your nail system is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 40 states.
FDA distribution: “Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0452-2019 (October 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0452-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.