BioZorb Marker. Radiographic soft tissue marker.
- Company
- Hologic, Inc
- Recall Initiated
- October 10, 2024
- Posted
- November 26, 2024
- Recall Number
- Z-0328-2025
- Quantity
- 12,710 units
- Firm Location
- Marlborough, MA
Reason for Recall
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
Distribution
Domestic: US Nationwide Distribution.
Lot / Code Info
Model No. F0405, F0404, F0331, F0231, F0221, F0304, F0303, F0203, F0202; UDI-DI: 15420045514065, 15420045514058, 15420045514041, 15420045514034, 15420045514027, 15420045514010, 15420045514003, 15420045513990, 15420045513983; Lot No. 22E24RH, 23A09RK, 23L23RP, 22E24RG, 23A09RJ, 23E03R, 23G28RW, 22F06RL, 22G26RQ, 22K25RA, 23A09RH, 23A30RP, 23C02RJ, 23H25RW, 23K04RC, 23K31RG, 24A30RG, 22D21RBB, 22F06RK, 22F29RK, 22G26RP, 22H24RM, 22J26RG, 22K25R, 22L22R, 22M20RM, 23A26RV, 23C02RH, 23E27RF, 23F29RT, 23H03R, 23H25RU, 23K04RA, 23L23RK, 24B02RD, 24B27RK, 22D21RAA, 22E24RA, 22F29RJ, 22G26RN, 22H24RL, 22J26RF, 22K21R, 22L22RA, 22M20RL, 23A26RU, 23C02RG, 23C30RQ, 23E03RA, 23F29RP, 23G28RV, 23H25RV, 23K02RB, 23K31RD, 23L23RH, 24A08RY, 24B01R, 24B27RL, 24C22RN, 22D21RZ, 22E24RB, 22F25RF, 22G26RM, 22H24RK, 22J26RD, 22K19RW, 22L22RB, 23C02RK, 23E25RY, 23F29RS, 23H24RP, 23K04RB, 23K31RF, 23L23RJ, 22D21RY, 22E24R, 22F25RD, 22G26RL, 22H22RT, 22J26RC, 22K19RV, 22L22RC, 23A09RN, 23H03RA, 23H31R, 23K04RD, 23K25RM, 22D21RX, 22E20RAA, 22F21R, 22G21RM, 22H22RS, 22J22RBB, 22K19RU, 22L22RF, 23A09RM, 23A30RQ, 23B24RZ, 23C30RP, 23D27RJ, 23E31RD, 23F28RZ, 23G31RJ, 23H24RQ, 23K02RA, 23K25RN, 22D20RV, 22E20RZ, 22F16RV, 22G21RL, 22H20R, 22J22RAA, 22K19RT, 22K25RB, 22L22RD, 23A09RL, 23B24RY, 23C28RJ, 23D27RH, 23E30RF, 23F29RQ, 23G31RH, 23H24RN, 23K02R, 23K25RL.
Root Cause
Device Design
Action Taken
Consignees were sent an URGENT: MEDICAL DEVICE RECALL letter by mail dated 10/24/24. The notification instructs consignees to quarantine all affected devices and share the recall notification with all surgeons in their practice that have used or planned to use the BioZorb Marker. Additionally, if product was further distributed the notice is to be forwarded to those customers. Affected devices will be returned to Hologic and coordination of return will be initiated by return of the Customer Response Form. Healthcare providers are recommended to be aware of reports of serious adverse events following the placement of the BioZorb Marker devices in breast tissue and to continue to monitor patients for signs of any adverse events. BioZorb Markers are not cleared to fill space in the tissue or improve cosmetic outcomes after procedures. Patients are recommended to contact their healthcare provider if they experience any adverse events following the placement of their BioZorb marker. Hologic states that there is no need to undergo explantation of the device unless advised by your healthcare provider. Patients who have received the BioZorb Marker and/or your provider is planning radiation therapy treatments, discuss the possible risks with your provider. Report any problems/complications and direct any questions regarding this recall to Hologic at breasthealth.support@hologic.com.