Home / Recalls / Straumann Manufacturing, Inc. / Z-1694-2018

Z-1694-2018 Class II Terminated

Recalled by Straumann Manufacturing, Inc. — Andover, MA

Recall Details

Product Type
Devices
Report Date
May 16, 2018
Initiation Date
March 23, 2018
Termination Date
May 2, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3046

Product Description

Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099

Reason for Recall

A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.

Distribution Pattern

Distributed US Nationwide and Puerto Rico.

Code Information

Lot LT830, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot LZ706, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MG929, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MT037, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot MZ441, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ289, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ579, Syringe Blister Lot NA438A, Exp 3/31/2019 Lot NP340, Syringe Blister Lot NA438A, Exp 3/31/2019

Other recalls by Straumann Manufacturing, Inc.

  • Z-0455-2019 Class II — Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are in (October 2, 2018)
  • Z-1695-2018 Class II — Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Numb (March 23, 2018)
  • Z-1698-2018 Class II — Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 0 (March 23, 2018)
  • Z-1696-2018 Class II — Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 0 (March 23, 2018)
  • Z-1693-2018 Class II — Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075 (March 23, 2018)
  • Z-1697-2018 Class II — Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Numb (March 23, 2018)
  • Z-0957-2017 Class II — Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant acc (November 23, 2016)
  • Z-0958-2017 Class II — Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant acces (November 23, 2016)
  • Z-2535-2016 Class II — Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: (July 14, 2016)
  • Z-2534-2016 Class II — Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 0 (July 14, 2016)