# FDA recall Z-0655-2020

> **CP Medical Inc** · Class II · device recall initiated 2019-10-18.

## Product

Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

## Reason for recall

Failed to meet USP minimum average value for knot pull (tensile) strength.

## Distribution

USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE

## Key facts

- **Recall number:** Z-0655-2020
- **Recalling firm:** CP Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-10-18
- **Report date:** 2019-12-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norcross, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0655-2020

## Citation

> AI Analytics. FDA recall Z-0655-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0655-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*