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iTotal Identity 3DP Porous Knee

Restor3d, Inc. · Model TCR-000-D005-010111 · UDI-DI 00840097515151

OOG Prescription
1
510(k) clearances
261
Adverse events
3
Recalls
36
Facilities

Description

iTotal Identity CR 3DP Porous iJigs Left

Recalls

DateFirmReason
2015-08-31ConforMIS, Inc.May contain small amounts of ethylene glycol residue
2015-08-31ConforMIS, Inc.May contain small amounts of ethylene glycol residue
2015-08-31ConforMIS, Inc.May contain small amounts of ethylene glycol residue

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Data 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.