Z-1219-2017 Class II Terminated
FDA device recall Z-1219-2017 was initiated by Zimmer Biomet, Inc. on Dec 15, 2016 and is designated Class II. Reason for recall: Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions… The recall status is terminated (terminated Jun 29, 2018). Affected quantity: 26.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 22, 2017
- Initiation Date
- Dec 15, 2016
- Termination Date
- Jun 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26
Product Description
Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265
Reason for Recall
Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
Distribution Pattern
Domestic: 0 Foreign: Singapore & Malaysia
Code Information
Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265; Lot No's: ZB160701, ZB160702, ZB160703, ZB160701, ZB160702, ZB160701, ZB160702, ZB160703, ZB160801, ZB160802, ZB160803, ZB160801, ZB160802
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1219-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026