Stabilization Screw

• 2 recalls, same reason

  • Ongoing Z-1319-2024 FDA Class II ·initiated 26 Jan 2024
  • Ongoing Z-1320-2024 FDA Class II ·initiated 26 Jan 2024

  This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.

• • Terminated Z-0397-2016 FDA Class II ·initiated 18 Nov 2015

  One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.

1. 1 May 2014 Cleared FDA 510(k) K131920
2. 18 Nov 2015 Recall initiated FDA recalls Z-0397-2016
3. 26 Jan 2024 Recall initiated FDA recalls Z-1319-2024
4. 26 Jan 2024 Recall initiated FDA recalls Z-1320-2024

510(k) Number

K131920 ↗

FDA product code

HWC

Device class

Class II

Regulation

21 CFR Part 888.3040

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code HWC (Screw, Fixation, Bone).

• Arthrex® AR-8933-14 by Arthrex, Inc.
• Arthrex® AR-18827P-09 by Arthrex, Inc.
• ACUMED CO-3350 by ACUMED LLC
• MAX VPCVARIABLE PITCH COMPRESSION SCREW 233240020 by Biomet Orthopedics, Inc.
• ACUMED 30-0261 by ACUMED LLC
• CLAW II ORTHOLOC 3DSi 40240220 by WRIGHT MEDICAL TECHNOLOGY, INC.
• RONDO' Washer ø16mm VT-65000 by Citieffe
• A.L.P.S.® 8513-18-207 851318207 by Biomet Orthopedics, Inc.
• Depuy DuPont Absorbable Set Screw by Depuy, Inc.
• Nonlinear Taper Lag Screw by Theken Surgical, Llc

• Neofit®

  Class IIb

  CE/MDD GUDID on market

• Neofuse

  Class IIa

  CE/MDD GUDID on market

• Ibs™

  Class IIb

  CE/MDD GUDID on market

• Kirschner wire

  Class IIb

  CE/MDD GUDID on market

See all devices from In2Bones SAS →