Intramedullary Bone Saw recallZ-0595-2020 · Zimmer Biomet, Inc. · initiated Oct 25, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Error in labeling
What the company is doing
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].
Recall details
- Recall number
- Z-0595-2020
- Status
- Terminated
- Initiated by the company
- Oct 25, 2019
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 34 units
- Product code
- LXH
- Distribution
- Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand
Product description
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665
Code information (models, lots, serial numbers)
Lot Numbers: 334360, 366680, 366670 UDI: (01)00880304386587(17)280805(10)334360 (01)00880304386587(17)280530(10)366680 (01)00880304386587(17)280530(10)366670
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INTRAMEDULLARY BONE SAW 475665Biomet Orthopedics, LLC · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 84224).
- Z-0594-2020 · TerminatedBiomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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