# FDA recall Z-1507-2023

> **Linkbio Corp.** · Class II · device recall initiated 2023-03-21.

## Product

LINK SLED Knee System:  ENDO SLED KNEE FEM COMP, SMALL  Item Number: 15-2020/40

## Reason for recall

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

## Distribution

NY, NV Foreign:  Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus

## Key facts

- **Recall number:** Z-1507-2023
- **Recalling firm:** Linkbio Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-21
- **Report date:** 2023-05-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rockaway, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1507-2023

## Citation

> AI Analytics. FDA recall Z-1507-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1507-2023. Source: US FDA. Licensed CC0.

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