Z-2875-2018Class II

Connecting Bolt, Model 14-442093

Name: Z-2875-2018 Connecting Bolt, Model 14-442093
Creator: Zimmer Biomet, Inc.
Published: 2018-06-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-06-18 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Connecting Bolt, Model 14-442093 on 2018-06-18. FDA classified it as Class II and gives the reason as "Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead to 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-2875-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-18
Posted: 2018-08-17
Terminated: 2020-03-26
Recalling firm: Zimmer GmbH
Product: Connecting Bolt, Model 14-442093
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead to fracture.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL notices to customers via courier service. Risk Manager were advised to take the following actions: 1. Review the 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 and return the Certificate of Acknowledgement form via email to [email protected]. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing the notice, call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]. Distributors are encouraged to do the following: Review th notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in 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. b. Request a Return Authorization Number through Fast SMS or by emailing [email protected] c. For each return, send a copy of Attachment 1 to [email protected]. d. Include a hardcopy of Attachment 1 in each carton of your return shipment for
Quantity in commerce: 247 units
Distribution: AR, AZ, CA, FL, GA, IN, KY, LA, MA, MI, MN, MO, MT, NJ, NY, OH, SC, TX, UT & WI
Product codes and lots: ...

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2875-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2875-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-17

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)