Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwitzerlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Zimmer BiometLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Zimmer CAS with 3 510(k) clearances and 2 device recalls. The most recent is a device recall dated Apr 19, 2015: Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;.
| Apr 19, 2015 | Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;Class II · Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or brea | Device recalls |
| Nov 3, 2014 | PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indClass II · Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that cou | Device recalls |
| Sep 11, 2014 | IASSIST KNEE SYSTEMK141601 · OLO | 510(k) clearances |
| Aug 20, 2013 | CAS PSI SHOULDERK131129 · KWS | 510(k) clearances |
| Mar 24, 2011 | NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCEK110054 · OLO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
