Straumann USA LLC is recalling 45 units of the TLX/TLC SP Guided Implant Driver, a stainless steel tool used with ratchets during dental procedures. These specific devices were distributed without laser-etched depth markings, which are necessary for clinicians to monitor placement during surgery. No incidents or injuries have been reported related to this defect, and the manufacturer has initiated this voluntary recall by letter.
The missing depth markings on the surgical driver can prevent a clinician from accurately seeing how deep a dental implant is being placed. This could result in the implant being set too shallowly or too deeply, which may cause complications or damage to the patient's jawbone or surrounding tissue.
Packaging Lot numbers: LGMZ8, GLKJ9; Lot number engraved on part: HTXT5.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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