Z-1463-2018Class II

The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following...

Name: Z-1463-2018 The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following...
Creator: Integra LifeSciences Corp.
Published: 2017-12-20
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2017-12-20 / Terminated / root cause: design

FDA source

Integra LifeSciences Corp. began a recall of The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506... on 2017-12-20. FDA classified it as Class II and gives the reason as "Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1463-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-20
Posted: 2018-04-20
Terminated: 2020-02-24
Recalling firm: Integra LifeSciences Corporation
Product: The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Humeral Stem Trial, 9mm TRL092002510 Humeral Stem Trial, 10mm TRL092002511 Humeral Stem Trial, 11mm TRL092002512 Humeral Stem Trial, 12mm TRL092002513 Humeral Stem Trial, 13mm TRL092002514 Humeral Stem Trial, 14mm TRL092002515 Humeral Stem Trial, 15mm TRL092002516 Humeral Stem Trial, 16mm
Product code: HWT Template
Reason for recall: Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.
Root cause tag: design
FDA root cause: Device Design
Action: Firm sent letters to consignees on December 20, 2017. Firm asked consignees to examine inventory and determine if consignee had affected product. Firm promised to send new stem trials along with a return shipping label. Firm asked to complete the Acknowledgment and Return Form and email or fax back to firm. For further questions, please call (609) 275-0500.
Quantity in commerce: 1619 units
Distribution: Worldwide Distribution - USA (nationwide) Distribution.
Product codes and lots: TRL092002506 Lot Numbers: 19419-1 15916-1 15457-1 201274-1 201893-1 2046177 TRL092002507 Lot Numbers: 19419-2 15916-2 15457-2 201274-2 201893-2 2046178 TRL092002508 Lot Numbers: 19419-3 15916-3 15457-3 201274-3 201893-3 2046179 TRL092002509 Lot Numbers: 19419-4 15916-4 15457-4 201274-4 201893-4 20461710 TRL092002510 Lot Numbers: 19419-5 15916-5 15457-5 201274-5 201893-5 20461711 TRL092002511 Lot Numbers: 19419-6 15916-6 15457-6 201274-6 201893-6 20461712 TRL092002512 Lot Numbers: 19419-7 15916-7 15457-7 201274-7 201893-7 20461713 TRL092002513 Lot Numbers: 19419-8 15916-8 15457-8 201274-8 201893-8 20461714 TRL092002514 Lot Numbers: 19419-9 15916-9 15457-9 201274-9 201893-9 20461715 TRL092002515 Lot Numbers: 19419-10 15916-10 15457-10 201274-10 201893-10 20461716 TRL092002516 Lot Numbers: 19419-11 15916-11 15457-11 201274-11 201893-11 20461717

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1463-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1463-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-20

Product code HWT

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)