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Synthes GmbH · Model 460.037 · UDI-DI 10887587055152
2
510(k) clearances
2,614
Adverse events (30 deaths)
15
Recalls
151
Facilities
Description
TI STERNAL LOCKING X PLATE 10 HOLES
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-09-10 | Alto Development Corp | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensio |
| 2019-09-10 | Alto Development Corp | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensio |
| 2019-09-10 | Alto Development Corp | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensio |
| 2019-09-10 | Alto Development Corp | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensio |
| 2019-09-10 | Alto Development Corp | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensio |
| 2015-10-19 | Synthes (USA) Products LLC | Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26 |
| 2015-07-22 | Synthes (USA) Products LLC | The end cap may loosen and detach making the instrument non-functional. No injuries reported. |
| 2015-05-29 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Ste |
| 2015-02-11 | EXP Pharmaceutical Services Corp | EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re |
| 2014-06-11 | PIONEER SURGICAL TECHNOLOGY, INC. | Lack of Sterility Assurance |
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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.