Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10.0979 Part of Medacta Shoulder System
Medacta Usa Inc
The hazard
Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10.0979 Part of Medacta Shoulder System
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model REF/UDI/Lot: 04.01.10.0970/07630542768910/2585086Model 04.01.10.0971/07630542768927/2585087Model 04.01.10.0972/07630542768934/2585088Model 04.01.10.0973/07630542768941/2585089Model 04.01.10.0974/07630542768958/2585090Model 04.01.10.0975/07630542768965/2585091Model 04.01.10.0976/07630542768972/2585092Model 04.01.10.0977/07630542768989/2585093Model 04.01.10.0978/07630542768996/2585094Model 04.01.10.0979/07630542769009/2585095UPC 07630542768910UPC 07630542768927UPC 07630542768934UPC 07630542768941UPC 07630542768958UPC 07630542768965UPC 07630542768972UPC 07630542768989UPC 07630542768996UPC 07630542769009Would you have heard about this one?
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