Medacta Usa Inc: Shoulder Prosthesis, Reverse Configuration
Recall Summary Medacta USA is recalling Short Monobloc Stem Broaches (surgical instruments in sizes 7-16) used during reverse shoulder replacement surgery because they position slightly off-center by about 0.2 mm, which could increase the risk of bone fracture in the upper arm. The affected instruments were distributed nationwide across multiple states. This is a Class II recall, meaning there is potential for serious health consequences but the risk of death is not likely.
- Recalling firm
- Medacta Usa Inc
- Product
- 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 Part of Medacta Shoulder System
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-30
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of CO, AR, IN, PA, UT, FL.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e7cfc1dd-e2f1-405c-8266-ba526d315935