Integrity Implants recalls FlareHawk Interbody Fusion System Instructions for Use (IFU's) due to potential cleaning parameter discrepancies in labeling. Affected users should verify their IFU version and contact the company for updates.
Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling material. The firm is initiating the field correction to ensure that updated information is provided to all accounts.
Integrity Implants is recalling the FlareHawk Interbody Fusion System Instructions for Use (IFU's) because they found a discrepancy in cleaning parameters in some labeling materials. This recall does not involve the actual medical devices but only the instructions for use, which are critical for safe surgical procedures.
The discrepancy in cleaning parameters could lead to incorrect cleaning procedures if the instructions are followed without the updated information. However, this is a labeling issue that does not affect the physical medical devices themselves.
Surgical teams and healthcare providers who have received the FlareHawk Interbody Fusion System Instructions for Use (IFU's) with the specified versions. Patients are not directly affected since the recall involves only the instructions, not the medical devices.
Check for FlareHawk Interbody Fusion System Instructions for Use (IFU's) with the following versions: IFU-0150 Rev E, STM-00001 Rev A, or STM-0336 Rev C. These are the specific labeling materials affected by the cleaning parameter discrepancy.
Check the version number on your FlareHawk Interbody Fusion System Instructions for Use (IFU) to confirm if it matches the affected versions listed.
No, the recall only affects the Instructions for Use (IFU's), not the physical medical devices. The devices themselves are not at risk.
Contact Integrity Implants directly to get updated instructions for use. They will provide the corrected materials.
No, patients are not directly affected since the recall involves only the instructions for use, not the medical devices.
We’ve drafted a message you can send Integrity Implants to request your refund or repair — edit it as you like.
Subject: Recall Z-0405-2019 — Integrity Implants Integrity Implants Hello, I own a Integrity Implants that is covered by recall Z-0405-2019 from Integrity Implants. 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.
