Z-0517-2020Class II

ASI 2.0 Calcar Trimmer Shaft for Use with Biomet Rasp, Model Number 110032331

Name: Z-0517-2020 ASI 2.0 Calcar Trimmer Shaft for Use with Biomet Rasp, Model Number 110032331
Creator: Zimmer Biomet, Inc.
Published: 2019-08-06
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-08-06 / Terminated

FDA source

Zimmer Biomet, Inc. began a recall of ASI 2.0 Calcar Trimmer Shaft for Use with Biomet Rasp, Model Number 110032331 on 2019-08-06. FDA classified it as Class II and gives the reason as "The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0517-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-06
Posted: 2019-11-22
Terminated: 2020-08-24
Recalling firm: Zimmer GmbH
Product: ASI 2.0 Calcar Trimmer Shaft for Use with Biomet Rasp, Model Number 110032331
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331.
FDA root cause: Under Investigation by firm
Action: On August 9, 2019 the firm distributed Urgent Medical Device Recall Communication letters by email instructing them to: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. This form must be returned even if you do not have affected products available to return in your territory. b. For each return, send a copy of Attachment 1 to [email protected]. c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Include a copy of Attachment 2 Certificate of Sterilization with returned instruments. e. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to [email protected]. a. Review the list of hospitals included with the email notification sent to your facility, which includes a list of hospitals that have already been notified of this recall. b. Identify whether there are any additional hospitals that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. 5. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility. 6. If you have further 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. Calls received out
Quantity in commerce: 73
Distribution: CA, IN, MN, NJ, NY, AR, LA, OH, KY, TX, CO (US) CA, CN, NL (International)
Product codes and lots: Model Number: 11032331 Lots: 784060, 662870

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0517-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0517-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22

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)