Recall Z-1114-2025 ยท EKS File, Pulp Canal, Endodontic
US Endodontics, LLC
Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK AP135253PK AP135313PK AP145213PK AP145253PK AP145313PK AP1GP213PK AP1GP253PK AP1GP313PK O.U.S. Products: EdgeFile X7 REF: SX70421MM SX70425MM SX70429MM SX70621MM SX70625MM SX70629MM SX7170421RF SX7170425RF SX7170429RF SX7170621RF SX7170625RF SX7170629RF SX720
| Date | Feb 6, 2025 (initiated Jan 2, 2025) |
| Status | Open, Classified |
| Reason | Due to devices being irradiated above the established specification which my result in package integrity issues. |
| Root cause | Under Investigation by firm |
| Action | On 01/02/2025, the firm email an "URGENT MEDICAL DEVICE CORRECTION NOTICE" to customer informing them that sterility of the product may have been compromised due to over irradiation during routine sterilization processing. Customers are instructed to: 1. Confirm if they have any of the impacted Lots. 2. if they have any of the impacted Lots, they are to evaluate the package seal for any potential seal breaches or degradation of the packaging material, which may indicate a lack of sterility in the product. 3. If there are any concerns with the package seal integrity, treat the device as non-st |
| Quantity | Total devices=789,729 (47,508 devices (U.S.) and 742,221 device (O.U.S.)) |
| Distribution | Worldwide - US Nationwide distribution in the state of GA and the countries of Australia, Canada, the European Union (specifically France, Germany, Italy, Poland, and Spain), and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.