Home / Recalls / Skeletal Kinetics, Llc / Z-0866-2021

Z-0866-2021 Class II Terminated

Recalled by Skeletal Kinetics, Llc — Addison, TX

Recall Details

Product Type
Devices
Report Date
January 27, 2021
Initiation Date
June 6, 2019
Termination Date
September 18, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

Product Description

OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

Reason for Recall

A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.

Distribution Pattern

U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.

Code Information

OsteoVation, Inject, 5cc (part number 390-2005, manufacturing lot number 1129957, label no. 12464) . UDI: (01) 0 0813845 02005 4 (17) 210401 (10) 1129957

Other recalls by Skeletal Kinetics, Llc

  • Z-2598-2020 Class II — CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usage: (April 6, 2020)
  • Z-2622-2020 Class II — OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 (April 6, 2020)
  • Z-2627-2020 Class II — SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: (April 6, 2020)
  • Z-2630-2020 Class II — SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Produc (April 6, 2020)
  • Z-2620-2020 Class II — OSTEOVATION, 5CC, INJECT FORMULA. Product Number: 390-2005, UDI: 813845020054 - (April 6, 2020)
  • Z-2596-2020 Class II — ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Usage (April 6, 2020)
  • Z-2636-2020 Class II — EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - P (April 6, 2020)
  • Z-2612-2020 Class II — OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 81384502003 (April 6, 2020)
  • Z-2619-2020 Class II — OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - (April 6, 2020)
  • Z-2628-2020 Class II — SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Product (April 6, 2020)