Home / Recalls / Alto Development Corp / Z-0243-2020

Z-0243-2020 Class II Terminated

Recalled by Alto Development Corp — Wall Township, NJ

Recall Details

Product Type
Devices
Report Date
November 6, 2019
Initiation Date
September 10, 2019
Termination Date
May 12, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
209 total

Product Description

A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.

Reason for Recall

Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.

Distribution Pattern

Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.

Code Information

327703, 327704, 330464, 344282

Other recalls by Alto Development Corp

  • Z-0242-2020 Class II — A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fix (September 10, 2019)
  • Z-0244-2020 Class II — A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fix (September 10, 2019)
  • Z-0245-2020 Class II — A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture f (September 10, 2019)
  • Z-0246-2020 Class II — A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fix (September 10, 2019)
  • Z-2098-2019 Class II — A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped El (June 21, 2019)
  • Z-0813-2018 Class II — Surgical punch; sealed pouches packed in punch shelf box Intended for use by (October 23, 2017)