Home / Recalls / In2Bones, SAS / Z-1283-2021

Z-1283-2021 Class II Terminated

Recalled by In2Bones, SAS — Ecully, N/A

Recall Details

Product Type
Devices
Report Date
March 31, 2021
Initiation Date
February 9, 2021
Termination Date
July 11, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
60 units

Product Description

In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.

Reason for Recall

This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the breakage of the burr during use.

Distribution Pattern

US Nationwide distribution in the state of TN.

Code Information

Model G01 01511, Batches 2009139 and 2001089 Model G01 01512, Batches 2007087 and 2011062

Other recalls by In2Bones, SAS

  • Z-1319-2024 Class II — I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 (January 26, 2024)
  • Z-1320-2024 Class II — I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180 (January 26, 2024)
  • Z-2869-2017 Class II — Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 S (July 13, 2017)
  • Z-0953-2017 Class II — NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 6 (December 19, 2016)
  • Z-0952-2017 Class II — SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du (December 19, 2016)
  • Z-0954-2017 Class II — NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is (December 19, 2016)
  • Z-0397-2016 Class II — IBS - Osteosynthesis screws for bone fixation Model S25 ST014. (November 18, 2015)
  • Z-1319-2015 Class II — DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangea (March 9, 2015)
  • Z-1318-2015 Class II — DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangea (March 9, 2015)