# FDA recall Z-2541-2017

> **Medtronic** · Class II · device recall initiated 2017-05-03.

## Product

Sutures.  POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404;   POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 30 VIO PRECUT  224E; Item Number: L405; POLSORB 4/0 60" REEL VIO 217T, Item Number: LL111; POLYSORB 0 18 UNDYED PRECUT, Item Number: L24; POLYSORB 0 18" UNDYED GS-21 DT, Item Number: CL14MG; POLYSORB 0 18" VIOLET PRECUT, Item Number: L27; POLYSORB 0 60 U/D REEL 203G, Item Number: LL104; POLYSORB 1 18" UNDYED PRECUT, Item Number: L25; POLYSORB 1 18" VIOLET GS-21 DT, Item Number: CL11MG; POLYSORB 1 30" VIOLET GS-21 DT, Item Number: CL6M; POLYSORB 1 30" VIOLET GS-22 DT, Item Number: CL885M; POLYSORB 1 30" VIOLET GS-25 DT, Item Number: CL64M; POLYSORB 2 VL 5 X 30" BGST-29 DT, Item Number: CLT633M; POLYSORB 2/0 18" UNDYED GS-10 DT, Item Number: CL52MG; POLYSORB 2/0 18" UNDYED GS-21 DT, Item Number: CL13MG; POLYSORB 2/0 18" VIOLET V-20 DT, Item Number: GL62MG; POLYSORB 2/

## Reason for recall

Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

## Distribution

Worldwide distribution.  US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.

## Key facts

- **Recall number:** Z-2541-2017
- **Recalling firm:** Medtronic
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-03
- **Report date:** 2017-06-21
- **Termination date:** 2019-07-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Haven, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2541-2017

## Citation

> AI Analytics. FDA recall Z-2541-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2541-2017. Source: US FDA. Licensed CC0.

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