Reported Jul 8, 2026 · Ongoing · Updated Sep 16, 2026
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,…
Medacta USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medacta Usa Inc · 3973 Delp St · Memphis, TN · 38118-6110
Is this the product you have?
- Short Monobloc Stem Broaches
- Size/REF7/04.01.10.0970, 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
- Lot codes and dates
- REF/UDI/Lot
04.01.10.0970/07630542768910/258508604.01.10.0971/07630542768927/258508704.01.10.0972/07630542768934/258508804.01.10.0973/07630542768941/258508904.01.10.0974/07630542768958/258509004.01.10.0975/07630542768965/258509104.01.10.0976/07630542768972/258509204.01.10.0977/07630542768989/258509304.01.10.0978/07630542768996/258509404.01.10.0979/07630542769009/2585095
- REF/UDI/Lot
- Amount recalled
- 50
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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