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implacross® E PE insert 0º
implantcast GmbH · Model 02333248 · UDI-DI 04048844206871
OQI
Prescription
5
510(k) clearances
172
Adverse events
4
Recalls
94
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-31 | Exactech, Inc. | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
| 2024-12-31 | Exactech, Inc. | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
| 2023-11-21 | Exactech, Inc. | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2022-08-25 | Zimmer, Inc. | The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include n |
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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.