FDAClass IIDecember 12, 2018

Biomet 20mm Compress Device Short Anchor Plug With recall

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.

Why was Biomet 20mm Compress Device Short Anchor Plug With recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 608740 UDI Number: (01)00880304461666(17)271113(10)608740

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.
Recalling firm
Zimmer Biomet, Inc.
Quantity
6 units
Distribution
US Nationwide Distribution in the states of IN, DC, MD
Recall date
December 12, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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