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9 reported ongoing
11 records in this archive. Latest source date May 19, 2025.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Class IIReported ongoing
Distribution: U.S: FL and TX O.U.S.: N/A
Due to incorrect product labeling
Class IIReported ongoing
Distribution: U.S Distribution: AZ, CA, IL, LA, and NY
Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.
Class IIReported ongoing
Distribution: US: IL, MO, CA, IN, MI, OK
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of MI, IL, ND, MO, OK.
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of MI, IL, ND, MO, OK.
Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint spac...
Class IIReported ongoing
Distribution: US: MO
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
Class IIReported ongoing
Distribution: U.S. Distribution to: TX
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Class IIReported terminated
Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, FL, MO, KS, CO, TX, KS, IL, PA, NY, NC, MI, MA, OK and the countries of Austria, Croatia, Germany, Irela...
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Class IIReported terminated
Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, FL, MO, KS, CO, TX, KS, IL, PA, NY, NC, MI, MA, OK and the countries of Austria, Croatia, Germany, Irela...
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 11 records, including 9 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.