The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog N

FDA device recall Z-1463-2018 · posted 2018-04-20 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

HWT

Quantity affected

1619 units

Distribution

Worldwide Distribution - USA (nationwide) Distribution.

Date initiated

2017-12-20

Date posted

2018-04-20

Date terminated

2020-02-24

Location

Plainsboro, NJ