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SMR STEMLESS
LIMACORPORATE SPA · Model 9013.55.078 · UDI-DI 08033390109918
PKC
Prescription
10
510(k) clearances
343
Adverse events
3
Recalls
75
Facilities
Description
SMR STEMLESS Shoulder - #LARGE Introducer
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-29 | Tornier, Inc | One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device). |
| 2019-10-10 | Zimmer Biomet, Inc. | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| 2019-08-21 | Zimmer GmbH | Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.