Home / Recalls / Stanmore Implants Worldwide Ltd. / Z-1623-2016

Z-1623-2016 Class II Terminated

Recalled by Stanmore Implants Worldwide Ltd. — Borehamwood, N/A

Recall Details

Product Type
Devices
Report Date
May 18, 2016
Initiation Date
April 12, 2016
Termination Date
January 26, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960

Reason for Recall

Incorrect component used to manufacture distal femoral replacement.

Distribution Pattern

US distribution to OH.

Code Information

Device Identifier: PIN 19960, Lot: 19960

Other recalls by Stanmore Implants Worldwide Ltd.

  • Z-3104-2017 Class II — JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intend (July 4, 2017)
  • Z-0822-2017 Class II — Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product (December 7, 2016)
  • Z-0820-2017 Class II — Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Shor (December 7, 2016)
  • Z-0824-2017 Class II — DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem (December 7, 2016)
  • Z-0821-2017 Class II — Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Shor (December 7, 2016)
  • Z-0823-2017 Class II — Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem (December 7, 2016)
  • Z-2553-2016 Class II — METS SMILES Total Knee Replacement (May 31, 2016)