Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article…

Is this the product you have?

• Brand NameHumeral Head Plate with Angular Stability
• with the following descriptionProximal Humeral Plate
• Article Numbers
  • 211341-10
  • 211341-4
  • 211341-7
  • 21134-4
  • 21134-5
  • 21135-4
  • 21136-4
  • 21136-5
  • 21136-7
  • 21137-4
  • 21137-7
  • 21138-4
  • 21139-4

Lot codes and dates

• Article Number (Lot Numbers)
  • 211341-10 (26/F63368
  • 26/F65625
  • 26/F66904
  • 26/F669041
  • 679/012410)
  • 211341-4 (26/F63366
  • 26/F65626
  • 26/F656261
  • 26/F66145
  • 26/F661451
  • 26/F66496
  • 26/F66905
  • 26/F669051
  • 26/F73497
  • 679/012439
  • 679/022450)
  • 211341-7 (26/F63367
  • 26/F65627
  • 26/F66146
  • 26/F66906
  • 679/012440)
  • 21134-4 (768/18758
  • 768/19642)
  • 21134-5 (778/201904)
  • 21135-4 (26/F67801
  • 768/21382)
  • 21136-4 (26/F65629
  • 26/F66907
  • 26/F67802
  • 26/F70071
  • 768/21383)
  • 21136-5 (770/101901)
  • 21136-7 (26/F65039
  • 26/F65630)
  • 21137-4 (26/F65631
  • 26/F67804
  • 768/21384)
  • 21137-7 (26/F65040)
  • 21138-4 (26/F65633
  • 26/F66908
  • 26/F67806)
  • 21139-4 (26/F65634
  • 26/F67807
  • 768/21386)

Amount recalled

292 units

This recall covers 17 products

The agency filed one notice per product. You are reading one of them; the other 16 are below.

• Volar Radius Plate with Angular Stability with the following description: Radius Plate…
• Claviculaplate with Angular Stability, with the below descriptions and associated…
• FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus…
• Pilonplate with Angular Stability, with the below descriptions and corresponding…
• Olecranonplate with Angular Stability with the below descriptions and corresponding…
• I.T.S. Straight Plate with Angular Stability with the below descriptions and…
• I.T.S. Screw System with the below descriptions and corresponding article numbers. 1.…
• Pelvic Reconstruction System (PRS) with the below descriptions and corresponding…
• I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and…
• Distal Humeral Plates with Angular Stability with the below descriptions and…
• I.T.S. LRS (Locking Reconstruction System) with the below descriptions and…
• I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with…

4 more are in the archive.

Where it was sold

• Nationwide
• AL
• AZ
• CA
• CO
• FL
• GA
• IL
• IN
• KS
• KY
• LA
• MA
• MD
• MI
• MN
• MO
• MS
• MT
• NE
• NJ
• NM
• NV
• OH
• OK
• PA
• SC
• TX
• WV

Why it was recalled

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

This product could cause temporary or reversible health problems — stop using it.