Z-1042-2015 Class II Terminated
FDA device recall Z-1042-2015 was initiated by Zimmer, Inc. on Nov 25, 2014 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Dec 1, 2015). Affected quantity: 1,091.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 11, 2015
- Initiation Date
- Nov 25, 2014
- Termination Date
- Dec 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,091
Product Description
Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
Reason for Recall
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
Distribution Pattern
Worldwide distribution: US nationwide, including Puerto Rico, South Korea, Singapore, Dominican Republic, Canada, Japan, and Germany.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1042-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026