🏥 Medical Devices Class I - Dangerous
A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.
All Recalls
95,075 total recalls in our database
fastener, fixation, nondegradable, soft tissue
Zimmer Biomet
🏥 Medical Devices Class I - Dangerous
It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
🏥 Medical Devices Class I - Dangerous
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
🏥 Medical Devices Class I - Dangerous
Label does not state that the product is heparin-coated.
🏥 Medical Devices Class I - Dangerous
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
CPT 12/14 COCR REVISION SIZE 2 180MM prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Zimmer Biomet
🏥 Medical Devices Class I - Dangerous
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
🏥 Medical Devices Class I - Dangerous
Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.
🏥 Medical Devices Class I - Dangerous
Label does not state that the product is heparin-coated.
🏥 Medical Devices Class I - Dangerous
Label does not state that the product is heparin-coated.
🏥 Medical Devices Class I - Dangerous
Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
🏥 Medical Devices Class I - Dangerous
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
🏥 Medical Devices Class I - Dangerous
Label does not state that the product is heparin-coated.
🏥 Medical Devices Class I - Dangerous
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Zimmer Biomet
🏥 Medical Devices Class I - Dangerous
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and disability
Zimmer Biomet
🏥 Medical Devices Class I - Dangerous
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
ReWalk Personal 6.0. Catalog number: 50-20-0004.
Argo Medical Technologies
🏥 Medical Devices Class I - Dangerous
Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
🏥 Medical Devices Class I - Dangerous
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Biomet
🏥 Medical Devices Class I - Dangerous
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
3M Company - Health Care Business
🏥 Medical Devices Class I - Dangerous
3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex rubber, but do not include the appropriate caution statement.