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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Zimmer Biomet, Inc.: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.

Agency Publication Date: March 20, 2017
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Affected Products

Product: Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number: 00784302008, Lot Number Expiry Date Before: July 2026

Lot Numbers:
Number
Product: Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number: 00225238016, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number: 00225240016 , Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number: 00225242016, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number: 00225244015, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number: 00225244016, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number:00225246015, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number:00225246016, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number:00225248015, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number:00225248016, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number:00225250015, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number:00225250016, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number:00225344015, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number:00225748004, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Fem IM Nail 14mmdx48cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number:00225748014, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Fem IM Nail 14mmdx50cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number:00225750004, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Fem IM Nail 14mmdx50cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number:00225750014, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Segmental malefemale taper, 200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number: 00585004620, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

Item Number: 00585004622, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

Item Number: 00585205217, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

Item Number: 00585205218, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

Item Number: 00585205219, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

Item Number: 00585205415, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

Item Number: 00585205416, Lot Number Expiry Date Before: July 2026

Lot Numbers:
Number
Product: Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

Item Number: 00585205417, Lot Number Expiry Date Before: September 2026

Lot Numbers:
Number
Product: Segmental fluted stem, 18x250mm bwd, Sterile,

Item Number: 00585205418, Lot Number Expiry Date Before: July 2026

Lot Numbers:
Number
Product: Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number: 00585205419, Lot Number Expiry Date Before: July 2026

Lot Numbers:
Number
Product: Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis- Specific Knee, Hip and Nail Implants

Item Number: 00585207419, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, metal/polymer, porous uncemented- Specific Knee, Hip and Nail Implants

Item Number: 00784301508, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Por fullct fem st 16x200mm, Sterile,

Item Number: 00784301608, Lot Number Expiry Date Before: July 2026

Lot Numbers:
Number
Product: Por fullct fem st 17x200mm, Sterile,

Item Number: 00784301708, Lot Number Expiry Date Before: July 2026

Lot Numbers:
Number
Product: Por fullct fem st 18x200mm, Sterile,

Item Number: 00784301808, Lot Number Expiry Date Before: July 2026

Lot Numbers:
Number
Product: Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number: 00784302008, Lot Number Expiry Date Before: July 2026

Lot Numbers:
Number
Product: Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number: 00992124033, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number
Product: Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Item Number: 00992125533, Lot Number Expiry Date Before: March 2027

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 76629
Status: Resolved
Manufacturer: Zimmer Biomet, Inc.
Manufactured In: United States
Units Affected: 33 products (9867)

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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.