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PedFuse®
SPINEFRONTIER, INC. · Model 01-80129-65 · UDI-DI 00190361012139
1
510(k) clearances
4,392
Adverse events (2 deaths)
15
Recalls
325
Facilities
Description
PedFuse Respond, SLD, 8.0mm x 65mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-04-12 | XTANT MEDICAL INC | The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium. |
| 2016-11-22 | Amendia, Inc | The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids. |
| 2015-04-07 | X Spine Systems Inc | The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. |
| 2015-03-11 | X Spine Systems Inc | One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label. |
| 2013-01-11 | Synthes USA HQ, Inc. | Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of |
| 2012-09-25 | Alphatec Spine, Inc. | The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated P |
| 2009-07-01 | Stryker Spine | The Trio 3.5MM Hex socket has been reported to break under high stresses. |
| 2009-04-30 | Stryker Spine | The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod |
| 2009-04-30 | Stryker Spine | The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod |
| 2009-04-02 | EBI, L.P. | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
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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.