Device Recall Depuy Mitek

Lot Codes: 1060792 1060824 1060841 1060851 BBBA0953D BBBA0953E BBBA0953F BBBA0953G BBBA1001T BBBA1001V BBBA1002H BBBA1002I BBBA1005D BBBA1005E BBBA1005F BBBA1005G BBBA1007J BBBA1008C BBBA1008E BBBA1010G BBBA1010H BBBA1010J BBBA1010K BBBA1012B BBBA1012C BBBA1012E BBBA1014A BBBA1014E BBBA1015F BBBA1015G BBBA1018E BBBA1018F BBBA1020B BBBA1020C

Neurological Devices

1

No

Worldwide Distribution - USA (nationwide) and the coutnries of United Arab Emirates, Australia, Belgium, Switzerland, Czech, Denmark, France, UK, Italy, Netherlands, Poland, and Slovakia.

DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing || Product Code: 281142 || Fluid Tissue Management

Lot Codes: 1060790 BBBA1001N BBBA1005C BBBA1006G BBBA1014C

Neurological Devices

1

No

Worldwide Distribution - USA (nationwide) and the coutnries of United Arab Emirates, Australia, Belgium, Switzerland, Czech, Denmark, France, UK, Italy, Netherlands, Poland, and Slovakia.

DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing || Product Code: 281103 || Fluid Tissue Management

Lot Numbers:  3403404 3411147 3415167 3415244 3417101 3418587

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of Austrailia Austria Belgium Canada China Estonia Finland France Germany Great Britain Indonesia Ireland Italy Japan Lebanon Lithuania Netherlands Poland Singapore Slovenia South Africa Spain Sweden and Switzerland

DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD || Product Code: 210811 || Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction.

Lot Numbers: 3409863 3415962 3416197 3416462

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of Austrailia Austria Belgium Canada China Estonia Finland France Germany Great Britain Indonesia Ireland Italy Japan Lebanon Lithuania Netherlands Poland Singapore Slovenia South Africa Spain Sweden and Switzerland

DePuy Mitek GRYPHON T BR Anchor w/ORTHOCORD¿ || Product Code: 210812 || Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction.

Lot Numbers:  3449990 3451672 3452663 3453946 3455144 3455703 3456883 3462226 3468839 3473244 3476092 3476648 3477802 3478695 3479693 3484277 3486069 3477068 3494964 3495725

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of Austrailia Austria Belgium Canada China Estonia Finland France Germany Great Britain Indonesia Ireland Italy Japan Lebanon Lithuania Netherlands Poland Singapore Slovenia South Africa Spain Sweden and Switzerland

DePuy Mitek GRYPHON P BR DS Anchor w/ORTHOCORD¿ || Product Code: 210813 || Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction.