Z-0516-2018Class II

Drill Bit Mini Quick Connect 1.0Mm, Ref 2312-20-200 & 2312-20-202, Non Sterile

Name: Z-0516-2018 Drill Bit Mini Quick Connect 1.0Mm, Ref 2312-20-200 & 2312-20-202, Non Sterile
Creator: Zimmer Biomet, Inc.
Published: 2017-06-12
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-06-12 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE on 2017-06-12. FDA classified it as Class II and gives the reason as "A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture". 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-0516-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-12
Posted: 2018-02-04
Terminated: 2018-06-29
Recalling firm: Zimmer GmbH
Product: Drill Bit Mini Quick Connect 1.0Mm, Ref 2312-20-200 & 2312-20-202, Non Sterile
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On June 12, 2017, Zimmer Biomet distributed Urgent Medical Device Recall Removal and Certificates of Acknowledgement notices to their customers via email and FedEx. Risk Manager Customer Responsibilities are the following: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative and quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete and return the Certificate of Acknowledgement via email to: [email protected] and retain a copy in your records. 5. If after reviewing the notice and if you have further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be sent by email to [email protected].
Quantity in commerce: 1,524 units
Distribution: AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WV. Internationally to: Australia, Chile, Cost Rica, Ecuador, Netherlands, Panama & Switzerland
Product codes and lots: 231220200 Item Number with the following Lot numbers 45785,46151, 47467, 48461, 48809, 100016 & 102325 231220202 Item Number with the following Lot Numbers: 45790, 48477, 48811, 100017, 101028 & 102338

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0516-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0516-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-04

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)