—#168863

Product

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 product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K062998
Affected lot / code info: Lot Number: 608740 UDI Number: (01)00880304461666(17)271113(10)608740

Why it was recalled

Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: US Nationwide Distribution in the states of IN, DC, MD

Timeline

Recall initiated: 2018-10-24
Terminated: 2020-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168863. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.