STAGEONE recallZ-1653-2020 · Biomet, Inc. · initiated Feb 26, 2020

Why it was recalled

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

FDA root cause category: Process control

What the company is doing

On 2/26/2020, Zimmer Biomet sent an "Urgent Medical Device Recall" letter via FEDEX to direct sales distributors, hospitals, and surgeons. In addition, an email was sent to all distributors alerting them of the recall. Customers were instructed to quarantine the product and a Zimmer Biomet representative would remove the affected product from the facility. They asked customers to complete and return the "Certificate of Acknowledgement" form indicating whether they had any of the affected lots.

Recall details

Recall number

Z-1653-2020

Status

Terminated

Initiated by the company

Feb 26, 2020

Posted by the FDA

Apr 3, 2020

Recalling firm

Biomet, Inc.

Quantity

230,001

Product code

KWY

FDA submissions

K052990

Distribution

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

Product description

BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• STAGEONE 431207

  Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal
  2 recalls0 reports

Product lines

• STAGEONEBiomet Orthopedics, LLC · 17 models · 0 reports · 18 recalls

Other devices under the same FDA submission

3 devices cleared under K052990 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• STAGEONE 431209

  Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 recalls0 reports
• STAGEONE 431217

  Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 recall0 reports
• STAGEONE 431213

  Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 85153).

• Z-1638-2020 · Terminated
  BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
• Z-1639-2020 · Terminated
  BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
• Z-1640-2020 · Terminated
  BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
• Z-1641-2020 · Terminated
  BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
• Z-1642-2020 · Terminated
  BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
• Z-1643-2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
• Z-1644-2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
• Z-1645-2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
• Z-1646-2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
• Z-1647-2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
• Z-1648-2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
• Z-1649-2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
• Z-1650-2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
• Z-1651-2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
• Z-1652-2020 · Terminated
  BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
• Z-1654-2020 · Terminated
  BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
• Z-1655-2020 · Terminated
  BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
• Z-1656-2020 · Terminated
  BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
• Z-1657-2020 · Terminated
  BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
• Z-1658-2020 · Terminated
  BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
• Z-1659-2020 · Terminated
  BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
• Z-1660-2020 · Terminated
  BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
• Z-1661-2020 · Terminated
  BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
• Z-1662-2020 · Terminated
  BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
• Z-1663-2020 · Terminated
  BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
• Z-1664-2020 · Terminated
  BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
• Z-1665-2020 · Terminated
  BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
• Z-1666-2020 · Terminated
  BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
• Z-1667-2020 · Terminated
  BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
• Z-1668-2020 · Terminated
  BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.