Z-0553-2019Class II

Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number...

Name: Z-0553-2019 Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number...
Creator: Zimmer Biomet, Inc.
Published: 2018-10-24
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-10-24 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of 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... on 2018-10-24. FDA classified it as Class II and gives the reason as "Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0553-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-24
Posted: 2018-12-04
Terminated: 2020-04-14
Recalling firm: Zimmer GmbH
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.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 6 units
Distribution: US Nationwide Distribution in the states of IN, DC, MD
Product codes and lots: Lot Number: 608740 UDI Number: (01)00880304461666(17)271113(10)608740

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0553-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0553-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-12-04

Product code JDI

K062998Class IIICompress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Biomet Manufacturing Corp / cleared 2007-01-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)