FIXIT & ecoFIX
S.B.M · Model Punch Tap - 5.5 mm and 6.5 mm · UDI-DI 03760154009744
HWX
Prescription
2
510(k) clearances
1,316
Adverse events
15
Recalls
299
Facilities
Description
Punch Tap to be used with diameter 5.5 mm and 6.5 mm FIXIT and ecoFIX suture anchors for rotator cuff repair.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-25 | Synthes (USA) Products LLC | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. |
| 2026-02-25 | Synthes (USA) Products LLC | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. |
| 2019-04-08 | Zimmer GmbH | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. |
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2012-04-13 | Smith & Nephew Inc | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| 2010-10-15 | Orthohelix Surgical Designs Inc | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and |
| 2010-10-15 | Orthohelix Surgical Designs Inc | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and |
| 2010-10-15 | Orthohelix Surgical Designs Inc | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and |
| 2010-04-21 | Blackstone Medical, Inc. | Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a si |
| 2010-04-21 | Blackstone Medical, Inc. | Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a si |
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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.