Recall Z-1463-2018 ยท HWT Template
Integra LifeSciences Corp.
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 Tr
| Date | Apr 20, 2018 (initiated Dec 20, 2017) |
| Status | Terminated |
| Reason | 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 | 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 | 1619 units |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.