Medacta Short Monobloc Stem Broaches
Short Monobloc Stem Broaches may increase the risk of fracture in the medial region of the proximal humerus.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Medacta USA Inc., of Memphis, Tennessee, began a recall on April 30, 2026, for Short Monobloc Stem Broaches, part of the Medacta Shoulder System.
The surgical instruments, used during shoulder arthroplasty procedures, do 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.
The FDA added the recall to its Enforcement Report on June 29, 2026. Distribution was nationwide in the states of CO, AR, IN, PA, UT, and FL.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
Short Monobloc Stem Broaches, Size/REF
- UDI-DI
- 07630542768910
- 07630542768927
- 07630542768934
- 07630542768941
- 07630542768958
- 07630542768965
- 07630542768972
- 07630542768989
- 07630542768996
- 07630542769009
- Lot
- 04.01.10.0970
- 2585086
- 04.01.10.0971
- 2585087
- 04.01.10.0972
- 2585088
- 04.01.10.0973
- 2585089
- 04.01.10.0974
- 2585090
- 04.01.10.0975
- 2585091
- 04.01.10.0976
- 2585092
- 04.01.10.0977
- 2585093
- 04.01.10.0978
- 2585094
- 04.01.10.0979
- 2585095
Details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Colorado, Arkansas, Indiana, Pennsylvania, Utah, Florida.
- Event ID
- 98944
- Recall No.
- Z-2618-2026
- Company
- Medacta Usa IncMemphis, Tennessee
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
