—#162744

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

FDA product code: HWT — Template
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution.

Timeline

Recall initiated: 2017-12-20
Posted by FDA: 2018-04-20
Terminated: 2020-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162744. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.