Z-0553-2019 Class II Terminated
FDA device recall Z-0553-2019 was initiated by Zimmer Biomet, Inc. on Oct 24, 2018 and is designated Class II. Reason for recall: Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted The recall status is terminated (terminated Apr 14, 2020). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 12, 2018
- Initiation Date
- Oct 24, 2018
- Termination Date
- Apr 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma. The Compress¿ Segmental Femoral Replacement System (Short Spindle and Anchor Plug) components are intended for uncemented use only.
Reason for Recall
Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted
Distribution Pattern
US Nationwide Distribution in the states of IN, DC, MD
Code Information
Lot Number: 608740 UDI Number: (01)00880304461666(17)271113(10)608740
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0553-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026