Medacta Short Monobloc Stem Broaches Recall
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Medacta Usa Inc is recalling 50 units of Short Monobloc Stem Broaches due to a positioning issue that may increase fracture risk during shoulder procedures.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Medacta Usa Inc initiated a voluntary recall of Short Monobloc Stem Broaches because the surgical instruments do not progressively translate to replicate implant geometry. The reaming guide and 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.
Which Products Are Affected
The recall affects 50 units of 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. These are part of the Medacta Shoulder System. Specific REF/UDI/Lot codes are listed in the recall. Distribution was limited to the states of CO, AR, IN, PA, UT, FL. Recall number Z-2618-2026. Classification: Class II.
What You Should Do
Consumers and healthcare providers should contact the recalling firm, Medacta Usa Inc, for additional information regarding the recall.
Why This Matters
The positioning deviation in these surgical instruments may increase the risk of fracture in the medial region of the proximal humerus during shoulder arthroplasty procedures.
Source
FDA recall number Z-2618-2026. Data from FDA enforcement report.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,314 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.