Home / Recalls / Ormco/Sybronendo / Z-0343-2016

Z-0343-2016 Class II Terminated

Recalled by Ormco/Sybronendo — Glendora, CA

Recall Details

Product Type
Devices
Report Date
December 9, 2015
Initiation Date
November 4, 2015
Termination Date
January 19, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
161 units

Product Description

Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.

Reason for Recall

Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.

Distribution Pattern

Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.

Code Information

Lot No. 21538339

Other recalls by Ormco/Sybronendo

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  • Z-2286-2020 Class II — Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq (January 14, 2020)
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  • Z-2836-2016 Class II — Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpre (August 31, 2016)
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  • Z-1321-2014 Class II — Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449- (March 25, 2014)
  • Z-1330-2014 Class II — Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081 (March 25, 2014)
  • Z-2194-2013 Class II — Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Ve (July 12, 2013)
  • Z-1084-2013 Class II — Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracke (March 8, 2013)