—#132553

Product

Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K113369
Affected lot / code info: Item No. 42-5299-001-00 Affected Lots: 56572679; 56573170; 56574318; 56575056; 56572918; 56573378; 56574538; 56575057; 56572975; 56573379; 56574540; 56575058; 56572978; 56574123; 56574618; 56575059; 56572981; 56574124; 56574619; 56575060; 56572982; 56574223; 56574620; 56575061; 56573071; 56574291; 56574629; 56575062; 56573115; 56574292; 56574630; 56575065; 56573116; 56574316; 56574631; 56575080; 56573154; 56574317; 56575018

Why it was recalled

Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fractured tip; Revision surgery to remove the fractured tip

Root cause (FDA determination)

Process control

Action the firm took

On 11/25/2014, URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications were sent to the affected distributors, hospital Risk Managers and Surgeons with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers, Surgeons, and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call the customer call center at 1-800-348-2759.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide distribution: US nationwide, including Puerto Rico, South Korea, Singapore, Dominican Republic, Canada, Japan, and Germany.

Timeline

Recall initiated: 2014-11-25
Posted by FDA: 2015-02-03
Terminated: 2015-12-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132553. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.