Reason: Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potentia...
Z-1480-2026March 11, 2026Nidau, N/A
B Braun Medical Inc
Class IIOngoing
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and ...
Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Z-1481-2026March 11, 2026Bethlehem, PA
B Braun Medical Inc
Class IIOngoing
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and inten...
Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Z-1482-2026March 11, 2026Bethlehem, PA
B Braun Medical Inc
Class IIOngoing
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be us...
Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Z-1483-2026March 11, 2026Bethlehem, PA
Encore Medical, LP
Class IIOngoing
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Reason: Knee and Humeral socket implants contain incorrect labeling.
Reason: Knee and Humeral socket implants contain incorrect labeling.
Z-1460-2026March 4, 2026Austin, TX
Medline Industries, LP
Class IIOngoing
Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL1...
Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag...
Z-1397-2026February 25, 2026Northfield, IL
Medline Industries, LP
Class IIOngoing
Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYNJ39225K; 3) WT BREAST PACK, Kit SKU DYNJ46620I; 4) ENDO ...
Reason: Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the via...
Z-1192-2026February 4, 2026Northfield, IL
Miach Orthopaedics
Class IIOngoing
BEAR Implant. Model Number: 1000.
Reason: Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
Reason: Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the via...
Z-1190-2026February 4, 2026Northfield, IL
Medicrea International
Class IIOngoing
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Reason: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Z-1038-2026January 21, 2026Rillieux La Pape
Medicrea International
Class IIOngoing
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Reason: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Z-1039-2026January 21, 2026Rillieux La Pape
Zimmer, Inc.
Class IIOngoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 m...
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ...
Z-0975-2026December 31, 2025Warsaw, IN
Zimmer, Inc.
Class IIOngoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 m...
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ...
Z-0976-2026December 31, 2025Warsaw, IN
Zimmer, Inc.
Class IIOngoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 m...
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ...
Z-0972-2026December 31, 2025Warsaw, IN
Zimmer, Inc.
Class IIOngoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 m...
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ...
Z-0978-2026December 31, 2025Warsaw, IN
Zimmer, Inc.
Class IIOngoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 m...
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ...
Z-0967-2026December 31, 2025Warsaw, IN
Zimmer, Inc.
Class IIOngoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 m...
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ...
Z-0969-2026December 31, 2025Warsaw, IN
Zimmer, Inc.
Class IIOngoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 m...
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ...
Z-0977-2026December 31, 2025Warsaw, IN
Zimmer, Inc.
Class IIOngoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 m...
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ...
Z-0980-2026December 31, 2025Warsaw, IN
Zimmer, Inc.
Class IIOngoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 m...
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ...
Z-0968-2026December 31, 2025Warsaw, IN
Zimmer, Inc.
Class IIOngoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 m...
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ...
Z-0974-2026December 31, 2025Warsaw, IN
Zimmer, Inc.
Class IIOngoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 m...
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ...
Z-0979-2026December 31, 2025Warsaw, IN
Zimmer, Inc.
Class IIOngoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 m...
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ...