Xiros Plc
United KingdomFDA 510(k) applicant, unverified
- Devices
- 2
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Xiros Plc makes
Xiros Plc manufactures Poly-Tapes, including versions with the FastLok fixation device and various sizes with woven construction variants. These are designed for medical fixation applications, providing secure attachment in surgical settings.
The company’s products fall under FDA Class II devices and are listed via 510(k) clearance. The manufacturer is based in the United States.
Catalogue
Poly-Tapes With The Fastlok Fixation Device Ref K010051
510(k) 510(k)- 510(k) 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Xiros Plc, initiated on 2006-05-17. By recorded status: 2 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 17 May 2006 Z-1500-06 Unclassified (pre-2012) Terminated 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.
- 17 May 2006 Z-1501-06 Unclassified (pre-2012) Terminated 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.
Frequently asked questions
How many devices does Xiros Plc have in the registry?
The registry currently lists 2 devices for Xiros Plc. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xiros Plc's devices?
Among its 2 most recently registered devices, Xiros Plc has devices listed in FDA 510(k) (2 devices).
What risk classes do Xiros Plc's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Xiros Plc's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Xiros Plc?
FDA recall records list 2 recalls initiated by Xiros Plc, the most recent initiated on 2006-05-17. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Xiros Plc in the registry?
The most recently registered devices listed for Xiros Plc include POLY-TAPES WITH THE FASTLOK FIXATION DEVICE and POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS).