Home / Recalls / Zimmer Manufacturing B.V. / Z-1341-2016

Z-1341-2016 Class II Terminated

Recalled by Zimmer Manufacturing B.V. — Mercedita, PR

Recall Details

Product Type
Devices
Report Date
April 13, 2016
Initiation Date
March 17, 2016
Termination Date
March 14, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
TBD

Product Description

Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty. REF 42-5114-008-18

Reason for Recall

The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.

Distribution Pattern

Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries (Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain).

Code Information

lot 62632101

Other recalls by Zimmer Manufacturing B.V.

  • Z-1674-2016 Class II — Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length (May 4, 2016)
  • Z-1677-2016 Class II — Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm L (May 4, 2016)
  • Z-1673-2016 Class II — Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length (May 4, 2016)
  • Z-1676-2016 Class II — Periarticular plating system, cancellous bone screw, partially threaded, hex hea (May 4, 2016)
  • Z-1678-2016 Class II — M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 (May 4, 2016)
  • Z-1679-2016 Class II — Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully (May 4, 2016)
  • Z-1684-2016 Class II — Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone sc (May 4, 2016)
  • Z-1683-2016 Class II — Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular (May 4, 2016)
  • Z-1680-2016 Class II — Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 4711 (May 4, 2016)
  • Z-1675-2016 Class II — Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm le (May 4, 2016)