Prosthesis, Toe, Hemi-, Phalangeal

Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal

Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.

Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, OrthoPro LLC, Salt Lake City, UT Hemi is designed to supplement firs

Labeling presented conflicting information as to whether device was sterile or not.

SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104

The firm discovered a lack of adequate documentation confirming sterility on certain products.

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037

There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.