Wall Township, NJ, United States
Alto Development Corp recalls
3 recalls recorded since 2018, most recently on 10 September 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 September 2019
- Terminated
- 12 May 2020
- Reason
- 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
- Distributed to AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, OK, SC, TX, UT, VT, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0244-2020, Z-0246-2020, Z-0242-2020, Z-0245-2020, Z-0243-2020
- A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.
- A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum.
- A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.
- A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.
- A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.
Terminated Class II Medical devices
- Recall started
- 21 June 2019
- Terminated
- 13 May 2020
- Reason
- Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.
- Distribution
- Distribution US Nationwide, Czech Republic, Italy, Israel, and UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2098-2019
- A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Fle
Terminated Class II Medical devices
- Recall started
- 23 October 2017
- Terminated
- 30 April 2019
- Reason
- Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.
- Distribution
- Worldwide Distribution - USA Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0813-2018
- Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.