Device Recall OMNI

Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.

OmniPod¿, Insulin Management System (US) || Catalog Number: PODZXP420 || Product Usage: || The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.

Lot Codes: L41908, L41910, F41935

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.

OmniPod¿, Insulin Management System (OUS) || Catalog Number: 14810 || Product Usage: || The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.

OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)

General Hospital and Personal Use Devices

2

Yes

Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan

OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right

Part No. CSF-40-12, Lot No. 132635

Orthopedic Devices

2

Yes

US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.

Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System || The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture).

OmniDiagnost User Interface PN 9896 000 59561, 9896 000 12381, 9896 000 58161;  The firm utilizes a ''site number'' specific to each unit: 101599, 103055, 103058, 100520, 100873, 101152, 101154, 101676, 101962, 102164, 102582, 102977, 103050, 103051, 103052, 103055, 103058, 103218, 103219, 104012, 104577, 104858, 104934, 105324, 105394, 13124, 38351, 50428, 76596, 76944, 76948, 82655, 83871, 83958, 84441, 84850, 85163, 85165, 86113, 86303, 86326, 86339, 86340, 86485, 86486, 86549, 86965, 86977, 87164, X1707, X1747, 104857

Radiology Devices

The firm distributed devices to 81 hospitals and medical centers located throughout the U.S.

OmniDiagnost System