Medacta Short Monobloc Stem Broaches recalled for proximal humerus fracture risk
What this means
Medacta's Short Monobloc Stem Broaches (sizes 7–16), used during shoulder replacement surgery, have a manufacturing issue that causes the surgical instruments to be positioned slightly off-center during the procedure. This misalignment may increase the risk of fractures in the upper arm bone.
- If you are a healthcare facility or surgeon using these broaches, contact Medacta USA to identify affected instruments by lot number.
- Do not use affected broaches for new shoulder replacement procedures.
- Review past procedures performed with these instruments; consult Medacta and your surgical team if you have questions about patient follow-up.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2618-2026Want us to check the next one for you?
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