Z-0021-2015Class II

Compress Face Reamer

Name: Z-0021-2015 Compress Face Reamer
Creator: Biomet, Inc.
Published: 2014-09-17
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-09-17 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of... on 2014-09-17. FDA classified it as Class II and gives the reason as "Investigation determined that units supplied were missing the 4x21 degree helix angle". 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-0021-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-17
Posted: 2014-10-06
Terminated: 2015-07-14
Recalling firm: Zimmer GmbH
Product: Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Product code: HTO Reamer
Reason for recall: Investigation determined that units supplied were missing the 4x21 degree helix angle.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On September 17, 2014, "URGENT MEDICAL DEVICE RECALL NOTICE" was sent to the consignee Biomet Global Supply Chain Center (GSCC) by email and FedEx. GSCC notified all of the customers within Europe, the Middle East, and Asia that received the affected product. The recall notification included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call (574) 372-1570.
Quantity in commerce: 4
Distribution: International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.
Product codes and lots: Catalog numbers: 32-481000 Lot Numbers: 615860, 765230 Catalog Number: 32-481001 Lot Number Identification: 121450, 392410, 765250, 974290

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0021-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0021-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-06

Product code HTO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)