Z-0871-2020Class II

ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332

Name: Z-0871-2020 ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332
Creator: Zimmer Biomet, Inc.
Published: 2019-12-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-12-19 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument on 2019-12-19. FDA classified it as Class II and gives the reason as "Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach". 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-0871-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-19
Posted: 2020-01-28
Terminated: 2020-08-11
Recalling firm: Zimmer GmbH
Product: ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer Biomet issued letter via email and FedEx on 12/17/19 stating reason for recall, health risk and action to take: Review this notification and ensure that affected personnel are aware of the contents. 2. 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. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. Questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
Quantity in commerce: 67 units
Distribution: US Nationwide and Foreign: countries of Canada, CHINA, NETHERLANDS
Product codes and lots: Lot Numbers: 827310, 711160, 203240

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0871-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0871-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-28

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)