Transform

medical_device

medical_device

Lot Numbers: 2016234237; 2016234240; 2016234242; 2016234243; 2016234245; 2016234246; 2016234247; 2016234248; 2016234249; 2016234351.

Orthopedic Devices

2

Yes

Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.

Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.

Lot Numbers: 2016244391; 2016244394; 2016244395; 2016244396; 2016244397; 2016244424; 2016244426; 2016244427; 2016244428; 2016244430.

Orthopedic Devices

2

Yes

Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.

Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.

Model numbers 240-099-011- Serial numbers 031111001-021, 040114001-029, 040130001-007, 040308001-023, 040322001-010, 040412001-020. 240-099-012- serial numbers 040130008-022, 040311001-015, 040322001-010, 040401001, 002, 004 and 005. 240-099-020-serial numbers 040212001-032, 040309001-007, 040313001-010. 240-099-021-serial numbers 040224001-021, 040313017. 240-099-050-serial numbers 031218001-005, 031218031-045

General and Plastic Surgery Devices

2

No

The products were distributed to 114 consignees.

Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold separately.