PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 12, 2018 Initiated: October 24, 2018 #Z-0553-2019

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

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
6 units
Distribution
US Nationwide Distribution in the states of IN, DC, MD
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Zimmer Biomet, Inc.. Units affected: 6 units.
Why was this product recalled? ▼
Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 12, 2018. Severity: Moderate. Recall number: Z-0553-2019.

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