Biomet recalls StageOne Hip Cement Spacer Mold w/Reinforcement (Item 431207) with specific lot numbers due to potential insufficient cleaning process or inadequate monitoring of cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Biomet is recalling certain StageOne Hip Cement Spacer Mold w/Reinforcement products because they may not have been cleaned properly during manufacturing. This could lead to contamination risks for patients using these medical devices.
The recall is due to potential insufficient cleaning process or inadequate monitoring of cleaning parameters during manufacturing. This could result in contamination of the medical device, which might pose a risk to patients during surgery.
Patients who received the recalled hip cement spacer molds during surgery. Medical professionals using these molds in surgical procedures are most at risk.
Check the product label for lot numbers: 964120, 668270, 595770, 400860, 854840, 867720, 867770, 386480, 539790, 700450, 930290, 215340, 457040, 615020, 588170, 588180, 963900, 963890, 737920, 805810, 036350, 527200, 527910, 976890, 977050, 977060, 239180, 239350, 680230, 914070, 436930, 586660, 718000, 996950, 152820, 447320, 583910, 489590, 688970, 983790, 237740, 600740, 804850, 281760, 610610, 251390, 640340, 858260, 328590, 712140, 712150, 238320, 430100, 753810, 953120, 816080, 816070, 227680, 647310, 057570, 057580, 759520, 759530, 656320, 787060, 107920, 107930, 737780, 115700, 737760, 737770, 754930, 754940, 754960, 754970, 754980, 202410, 202420, 520120, 520130, 520140, 520150, 754960R, 705550, 964100R, 680230R, 807460, 825790R, 027710R, 766730, 520990, 520980, 521010, 234640, 234680, 208540R, 867750R, 347510, 347520, 348000, 347990, 318490, 318510, 318530, 318540, 337310, 337330, 350230, 337340, 350220, 350240, 383530, 449960, 449970, 350210, 449950, 457040R. Also check for UDI numbers starting with (01)00880304447165.
Look for lot numbers listed in the recall notice to determine if your product is affected.
Biomet recalls these hip cement spacer molds due to potential insufficient cleaning process or inadequate monitoring of cleaning parameters during manufacturing.
Check the product label for lot numbers: 964120, 668270, 595770, 400860, 854840, 867720, 867770, 386480, 539790, 700450, 930290, 215340, 457040, 615020, 588170, 588180, 963900, 963890, 737920, 805810, 036350, 527200, 527910, 976890, 977050, 977060, 239180, 239350, 680230, 914070, 436930, 586660, 718000, 996950, 152820, 447320, 583910, 489590, 688970, 983790, 237740, 600740, 804850, 281760, 610610, 251390, 640340, 858260, 328590, 712140, 712150, 238320, 430100, 753810, 953120, 816080, 816070, 227680, 647310, 057570, 057580, 759520, 759530, 656320, 787060, 107920, 107930, 737780, 115700, 737760, 737770, 754930, 754940, 754960, 754970, 754980, 202410, 202420, 520120, 520130, 520140, 520150, 754960R, 705550, 964100R, 680230R, 807460, 825790R, 027710R, 766730, 520990, 520980, 521010, 234640, 234680, 208540R, 867750R, 347510, 347520, 348000, 347990, 318490, 318510, 318530, 318540, 337310, 337330, 350230, 337340, 350220, 350240, 383530, 449960, 449970, 350210, 449950, 457040R.
Check the product label for lot numbers to determine if your product is affected. If it is, contact Biomet for further instructions.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1653-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1653-2020 from Biomet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
