Zimmer Biomet, Inc.: The set screw is not able to advance or reverse from the original position in the nail.

Agency Publication Date: November 14, 2018

Affected Products

Product: 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

Lot Numbers:

number

Product: 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

Lot Numbers:

number

Product: 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

Lot Numbers:

number

Product: 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

Lot Numbers:

number

Product: 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

Lot Numbers:

number

Product: 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

Lot Numbers:

number

Product: 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

Lot Numbers:

number

Product: 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

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81223

Status: Resolved

Manufacturer: Zimmer Biomet, Inc.

Manufactured In: United States

Units Affected: 8 products (2,163 in total (expanded))

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot number 371540

Lot Numbers:

number

Lot number 133240 971270

Lot Numbers:

number

Lot number 157410 171840

Lot Numbers:

number

Lot number 063610 063630 816520

Lot Numbers:

number

Lot number 945090 945230

Lot Numbers:

number

Lot number 145060 901680 901690

Lot Numbers:

number

Lot number 558260 558270

Lot Numbers:

number

Lot number 901770

Lot Numbers:

number