FX SHOULDER is recalling 4 units of the Centered Glenosphere w/Screw (32 mm), a shoulder implant component. The recall was initiated because boxes labeled as containing a 'centered' glenosphere may actually contain an 'eccentric' glenosphere. This packaging error could lead to the surgical implantation of an incorrect device that does not match the patient's anatomical requirements or the surgeon's plan. This recall affects products distributed in New Jersey with Lot number U0191.
If an eccentric glenosphere is mistakenly implanted instead of a centered one, it can cause joint instability, limited range of motion, or premature wear of the shoulder replacement. This may result in the need for additional corrective surgery to replace the incorrect component.
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If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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