Medacta Shoulder System Short Monobloc Stem Broaches
Medacta is recalling Short Monobloc Stem Broaches for the Shoulder System due to a risk of humerus fracture during surgery.
Healthcare providers should immediately identify and quarantine all affected broaches in their inventory and contact Medacta for return instructions.
Why it was recalled
Medacta is recalling specific sizes of Short Monobloc Stem Broaches used in shoulder arthroplasty procedures. The instruments do not correctly replicate implant geometry, causing the reaming guide and stem reamer to be positioned too laterally, which may increase the risk of fracture in the medial region of the proximal humerus.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Short Monobloc Stem Broaches, Size/REF
- Lot code
- 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
- UDI-DI
- 07630542768910, 07630542768927, 07630542768934, 07630542768941, 07630542768958, 07630542768965, 07630542768972, 07630542768989, 07630542768996, 07630542769009
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Editorial summary by Recall Canary · summary updated 2026-06-30 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification