Sonendo recalls GentleWave APM Procedure Instrument with Matrix REF GW-APM-PI02 due to erroneous unit carton labels. Affected units have specific UDI-DI codes and lot numbers.
Procedure Instruments with erroneous unit carton labels.
Sonendo is recalling its GentleWave APM Procedure Instrument with Matrix REF GW-APM-:02 because of incorrect carton labels. This could lead to confusion about which units are being used, potentially causing errors in dental procedures.
The procedure instruments have incorrect carton labels, which could lead to confusion about which units are being used. This might cause errors in dental procedures if the wrong instruments are selected.
Dental professionals using the GentleWave APM Procedure Instrument with Matrix REF GW-APM-PI02 are likely affected. Those who have the specific UDI-DI code 00858395006318 and lot number W2022080941R are most at risk.
Check for the UDI-DI code 00858395006318 and lot number W2022080941R on the carton. The product is labeled as GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02.
Verify the UDI-DI code 00858395006318 and lot number W2022080941R on the carton.
The recalled instrument is GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02.
Affected units have UDI-DI code 00858395006318 and lot number W2022080941R.
No immediate stop is required; check the carton labels for the specific UDI-DI code and lot number.
We’ve drafted a message you can send Sonendo to request your refund or repair — edit it as you like.
Subject: Recall Z-0233-2023 — Sonendo Sonendo Hello, I own a Sonendo that is covered by recall Z-0233-2023 from Sonendo. 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.
