Z-1009-2018Class II

fastener, fixation, nondegradable, soft tissue

Name: Z-1009-2018 fastener, fixation, nondegradable, soft tissue
Creator: Zimmer Biomet, Inc.
Published: 2017-10-25
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-10-25 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of fastener, fixation, nondegradable, soft tissue on 2017-10-25. FDA classified it as Class II and gives the reason as "It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device". 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-1009-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-25
Posted: 2018-03-14
Terminated: 2020-05-12
Recalling firm: Zimmer GmbH
Product: fastener, fixation, nondegradable, soft tissue
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: In October of 2017 an URGENT MEDICAL DEVICE RECALL LETTER was issued to customers requesting that any remaining product be quarantined and returned to recalling firm. Questions or concerns can be directed to 574-371-3071.
Quantity in commerce: 429 units
Distribution: TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT
Product codes and lots: Item # 110019010 Lot #'s 017350 141990 142000 142020 167190 240720 240740 240770 257970 398710 398730 398740 398750 421780 421790 421800 465910 504120 813190 940370

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1009-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1009-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14

Product code MBI

K143037Class IISnapShot Fixation SystemBiomet Manufacturing Corp / cleared 2015-01-20

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)