Z-2059-2017Class II

Bone Dowell Harvest Tubes

Name: Z-2059-2017 Bone Dowell Harvest Tubes
Creator: Zimmer Biomet, Inc.
Published: 2017-04-12
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-04-12 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Bone Dowell Harvest Tubes on 2017-04-12. FDA classified it as Class II and gives the reason as "mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part". 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-2059-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-12
Posted: 2017-04-25
Terminated: 2017-11-03
Recalling firm: Zimmer GmbH
Product: Bone Dowell Harvest Tubes
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 4/12/2017 URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Quantity in commerce: 49
Distribution: No US distribution. JAPAN NETHERLANDS SINGAPORE SWITZERLAND
Product codes and lots: Part Number: 900738 Lot Number (LN): 889990

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2059-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2059-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-10

Product code LXH

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)