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PMT® Halo Systems

PMT CORPORATION · Model 1211-123 · UDI-DI 00650551111481

HAX Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

HALO, 1203-5 VEST SMALL, ACRYLIC LINER, 1211-1 LARGE OPEN BACK RING, 1206-33 HEADBLOCKS, 1206-11 TRACTION BAIL

Recalls

Date	Firm	Reason
2018-06-21	Ossur Americas	Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium
2018-06-21	Ossur Americas	Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium
2018-06-21	Ossur Americas	Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium
2018-06-21	Ossur Americas	Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium
2014-09-08	Instrumed International, Inc.	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08	Instrumed International, Inc.	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08	Instrumed International, Inc.	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08	Instrumed International, Inc.	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08	Instrumed International, Inc.	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08	Instrumed International, Inc.	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a

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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.