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PMT CORPORATION HALO

PMT CORPORATION · Model 1201-35 · UDI-DI 00650551146964

HAX Prescription
1
510(k) clearances
26
Adverse events
13
Recalls
8
Facilities

Description

HEADBLOCK PARTS REPLACEMENT KIT: (4) 1 3/4" SHCS, (8) WASHERS, (4) LOCK WASHERS, (8) SET SCREWS, (2) BOLT STRAPS, (2)ALLEN WRENCH FOR OPEN BACK RINGS

Recalls

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2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a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