Zimmer Biomet recalls OsteoGen implantable bone growth stimulators with serial numbers expiring before March 31, 2019 due to lack of validation for product cleanliness.
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Zimmer Biomet is recalling OsteoGen implantable bone growth stimulators that were manufactured without sufficient validation of cleanliness. This affects specific serial numbers and models sold before March 31, 2019. The issue could potentially lead to contamination risks during medical procedures.
The product was not validated to ensure consistent cleanliness parameters were met during manufacturing. This could lead to contamination risks if the device is used in medical procedures, though the recall does not specify a direct risk of injury or illness.
Patients using the OsteoGen implantable bone growth stimulators with specific serial numbers and models listed in the recall are affected. Medical professionals who have implanted these devices are at higher risk due to potential contamination during surgery.
Check the serial number on the device. Affected models include OsteoGen 20/S, 20/SL, 20/M, 40/S, 40/SL, 40/M, and 40/ML. Serial numbers expire before March 31, 2019, and are listed in the recall notice.
Look for the serial number on the device to determine if it is listed in the recall.
The OsteoGen implantable bone growth stimulator is indicated for the treatment of long bone nonunions.
Affected models include OsteoGen 20/S, 20/SL, 20/M, 40/S, 40/SL, 40/M, and 40/ML with specific serial numbers listed in the recall.
The recall does not specify a need to stop using the device immediately; affected devices should be checked against the list of serial numbers.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0286-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0286-2019 from Zimmer 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.
