# FDA recall Z-1317-2023

> **Limacorporate S.p.A** · Class II · device recall initiated 2023-02-21.

## Product

SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

## Reason for recall

Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation.

## Distribution

US: MO

## Key facts

- **Recall number:** Z-1317-2023
- **Recalling firm:** Limacorporate S.p.A
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-21
- **Report date:** 2023-04-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Daniele Del Friuli, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1317-2023

## Citation

> AI Analytics. FDA recall Z-1317-2023. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1317-2023. Source: US FDA. Licensed CC0.

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