The humeral stems trials are packaged in a kit for Titan Modular… — Class II medical device recall Z-1463-2018
Terminated recall by Integra LifeSciences Corp., reported 2018-05-02, distributed nationwide. Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during
| Recall number | Z-1463-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2017-12-20 |
| Classified | 2018-04-20 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2020-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 1,619 units |
| Reason classes | device malfunction |
| Lot numbers | 15457-1, 15457-10, 15457-11, 15457-2, 15457-3, 15457-4, 15457-5, 15457-6, 15457-7, 15457-8, 15457-9, 15916-1, 15916-10, 15916-11, 15916-2, 15916-3, 15916-4, 15916-5, 15916-6, 15916-7, 15916-8, 15916-9, 19419-1, 19419-10, 19419-11, 19419-2, 19419-3, 19419-4, 19419-5, 19419-6, 19419-7, 19419-8, 19419-9, 201274-1, 201274-10, 201274-11, 201274-2, 201274-3, 201274-4, 201274-5 and 36 more |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1463-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.