FDA recall Z-2714-2024

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c) EXTREMITY, REF DYNJ900847A; d) HAND-LF, REF DYNJ902619G; e) HIP PINNING CDS, REF CDS984009C; f) HIP PINNING/TFN/ANTERIOR HIP, REF DYNJ902380K; g) KNEE, REF DYNJ904771B; h) KNEE ARTHROSCOPY, REF DYNJ905519D; i) KNEE ARTHROSCOPY, REF DYNJ906273F; j) KNEE ARTHROSCOPY, REF DYNJ909747; k) KNEE ARTHROSCOPY V, REF DYNJS2029D; l) LAMINECTOMY, REF DYNJ907159A; m) LOWER EXTREMITY, REF DYNJ904767A; n) LOWER EXTREMITY, REF DYNJ905518F; o) LOWER EXTREMITY, REF DYNJ909938; p) MINOR EXTREMITY, REF DYNJ909939; q) PODIATRY, REF DYNJ906275D; r) SHOULDER, REF DYNJ904769C; s) SHOULDER, REF DYNJ905511D; t) SHOULDER, REF DYNJ909749; u) SHOULDER ARTHROSCOPY, REF DYNJ906274F; v) SHOULDER ARTHROSCOPY CDS, REF CDS984008C; w) SOUTH EXTREMITY, REF DYNJ909212A; x) SPINE, REF DYNJ905512F; y) TOTAL, REF DYNJ909704; z) TOTAL HIP, REF DYNJ907157A; aa)

Reason for recall

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

Distribution

Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

Key facts

Status
Ongoing
Initiation date
2024-03-22
Report date
2024-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2714-2024