Z-1815-2016Class II

Various trauma and sports medicine instruments and implants. guide, surgical, instrument

Name: Z-1815-2016 Various trauma and sports medicine instruments and implants. guide, surgical, instrument
Creator: Biomet, Inc.
Published: 2016-04-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-04-01 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Various trauma and sports medicine instruments and implants. guide, surgical, instrument on 2016-04-01. FDA classified it as Class II and gives the reason as "Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is...". 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-1815-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-01
Posted: 2016-05-26
Terminated: 2017-05-23
Recalling firm: Zimmer GmbH
Product: Various trauma and sports medicine instruments and implants. guide, surgical, instrument
Product code: FZX Guide, Surgical, Instrument
Reason for recall: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 2016, to all affected customers. Customers were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Distribution: Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
Product codes and lots: Part #'s 281001080 281001100 35-351208 35-351534 35-351564 Lot #'s 606200 606210 606220 614280 661690 661700 661660 755290 764390 764400 621850

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1815-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1815-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-26
Z-1816-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-26
Z-1817-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-26
Z-1818-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-26
Z-1819-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-26
Z-1820-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-26
Z-1821-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-26
Z-1822-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-26
Z-1823-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-26
Z-1824-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-26
Z-1825-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-26
Z-1826-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-26
Z-1827-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-26
Z-1828-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-26

Product code FZX

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)