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.
FDA Recall Z-0553-2019 · Posted None
Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeJDI
Date Initiated2018-10-24
Date Terminated2020-04-14
Product Quantity6 units
Reason for Recall
Potential metal burrs in the holes of the device preventing
the appropriate drill and transverse pins from being inserted
Firm Action
Zimmer Biomet initiated recall by letter on 10/24/18 to distributors and hospitals advising of the problem and action to be taken-locate quarantine and return product. Complete Inventory Return Certification Form. Questions or concerns call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
Root Cause
Employee error
Distribution Pattern
US Nationwide Distribution in the states of IN, DC, MD
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.