Z-0595-2020Class II

Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item...

Name: Z-0595-2020 Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item...
Creator: Zimmer Biomet, Inc.
Published: 2019-10-25
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-10-25 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665 on 2019-10-25. FDA classified it as Class II and gives the reason as "Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0595-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-25
Posted: 2019-12-03
Terminated: 2020-04-30
Recalling firm: Zimmer GmbH
Product: Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL letter via FedEx and email on 10/25/19. The letter identifies the reason for recall, health risk and action to take: Review this notification and ensure that affected personnel are aware of the contents. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. Questions call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be emailed to [email protected].
Quantity in commerce: 34 units
Distribution: Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand
Product codes and lots: Lot Numbers: 334360, 366680, 366670 UDI: (01)00880304386587(17)280805(10)334360 (01)00880304386587(17)280530(10)366680 (01)00880304386587(17)280530(10)366670

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0595-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0594-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-11	2019-12-03
Z-0595-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-11	2019-12-03

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