HXJClass I

Staple Driver

Orthopedic · 21 CFR 888.4540

MDR events1All time

Recalls2All time

Registered firms46Currently listed

510(k) clearances6All time

Recent MDR events

1 adverse event reports on file

STAPLE DRIVER/ EXTRACTOR/ HXJMar 5, 2009
InjuryBrooks Manufacturing Site1020279-2009-00510

Event type breakdown

Injury1

Most-reported manufacturers

Brooks Manufacturing Site1

Recalls

2 recall events for this product code

Xiros Plc
TerminatedSep 13, 2006
Neoligaments Staple Impactor, 6 mm Staple Impactor: 202-3001
The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles.
Z-1500-06 · View FDA record ↗
Xiros Plc
TerminatedSep 13, 2006
Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010
The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles.
Z-1501-06 · View FDA record ↗

Registered firms

46 firms currently registered for this product code

510(k) clearances

6 clearances for this product code