Recall Z-1647-2020
Biomet, Inc. · initiated February 26, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
Codes / lots: ***Lot Numbers*** 978860, 087790, 087800, 157940, 558560, 564460, 052410, 052420, 052430, 052470, 052480, 230620, 230650, 575290, 767190, 766930, 789110, 031190, 031210, 031320, 265710, 349900, 654570, 927670, 767300, 817690, 188780, 188790, 932920, 205930, 429810, 655510, 092640, 757250, 771000, 683180, 803570, 217230, 197360, 291810, 799130, 552560, 974130, 249280, 249290, 233870, 188790R, 547700, 116180, 071090, 071100, 116160, 784730, 946240, 767190R, 487340, 552590, 655510R, 431450, 617650, 617770, 736810, 988930, 934780, 920630, 092640R, 552560R, 799130R, 920630R, 233870R, 291810R. ***UDI Numbers*** (01)00880304521155(17)160628(10)978860, (01)00880304521155(17)160728(10)087790, (01)00880304521155(17)160728(10)087800, (01)00880304521155(17)160728(10)157940, (01)00880304521155(17)160831(10)558560, (01)00880304521155(17)160928(10)564460, (01)00880304521155(17)170228(10)052410, (01)00880304521155(17)170228(10)052420, (01)00880304521155(17)170228(10)052430, (01)00880304521155(17)170228(10)052470, (01)00880304521155(17)170228(10)052480, (01)00880304521155(17)180108(10)230620, (01)00880304521155(17)180108(10)230650, (01)00880304521155(17)180215(10)575290…
Reason for recall
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1647-2020
- Initiated
- February 26, 2020
- Posted by FDA
- April 3, 2020
- Terminated
- July 29, 2021
- Product code
- KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Quantity
- 230,001
- 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…
- Recalling firm
- Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1638-2020 Class II | BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1639-2020 Class II | BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1640-2020 Class II | BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1641-2020 Class II | BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1642-2020 Class II | BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1643-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1644-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1645-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1646-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1648-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1649-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1650-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1651-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1652-2020 Class II | BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1653-2020 Class II | BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1654-2020 Class II | BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1655-2020 Class II | BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1656-2020 Class II | BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1657-2020 Class II | BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1658-2020 Class II | BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1659-2020 Class II | BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1660-2020 Class II | BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1661-2020 Class II | BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile…Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1662-2020 Class II | BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1663-2020 Class II | BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1664-2020 Class II | BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1665-2020 Class II | BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1666-2020 Class II | BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1667-2020 Class II | BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |
| Z-1668-2020 Class II | BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 02/26/2020Terminated |