Home / Recalls / Linvatec Corp. dba ConMed Linvatec / Z-2151-2012

Z-2151-2012 Class II Terminated

Recalled by Linvatec Corp. dba ConMed Linvatec — Largo, FL

Recall Details

Product Type
Devices
Report Date
August 15, 2012
Initiation Date
July 6, 2012
Termination Date
November 21, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

Product Description

PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.

Reason for Recall

ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm.

Distribution Pattern

Worldwide Distribution -- US and Korea.

Code Information

Lot 318455

Other recalls by Linvatec Corp. dba ConMed Linvatec

  • Z-1680-2013 Class II — ***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irriga (May 30, 2013)
  • Z-1681-2013 Class II — ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for join (May 30, 2013)
  • Z-1340-2013 Class II — Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and (March 18, 2013)
  • Z-1619-2013 Class II — GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mar (March 6, 2013)
  • Z-0917-2013 Class III — D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage (January 24, 2013)
  • Z-0916-2013 Class III — D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Syste (January 24, 2013)
  • Z-0789-2013 Class II — ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic (November 15, 2012)
  • Z-0066-2013 Class II — "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CON (June 26, 2012)
  • Z-0065-2013 Class II — "***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CON (June 26, 2012)
  • Z-0067-2013 Class II — "***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED (June 26, 2012)