# FDA recall Z-1000-2019

> **Ossur Americas** · Class II · device recall initiated 2018-06-21.

## Product

Ossur CB Resolve, Sterile,    Part/ Description:   505300C/ CB RESOLVE STERILE UNIT SML;  505400C/ CB RESOLVE STERILE UNIT STD;  505500C/ CB Resolve Sterile Unit LRG;  515300C/ CB RESOLVE RING KIT SM-No App;  515400C/ CB RESOLVE RING KIT STD-No App;  515500C/ CB RESOLVE RING KIT LG-No App;  540C/ CB RESOLVE COMPONENT TRAY;  553CB/ CB RING TRAY SM;  554CB/ CB RING TRAY STD;  555CB/ CB RING TRAY LG;  505301C/ Kit Closed Back Halo Sm;  505401C/ Kit Closed Back Halo Md;  505501C/ Kit Closed Back Halo Lg

## Reason for recall

Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

## Distribution

U.S.: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, AL, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA;    Foreign: Australia, Germany, New Zealand, Belgium

## Key facts

- **Recall number:** Z-1000-2019
- **Recalling firm:** Ossur Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-21
- **Report date:** 2019-03-20
- **Termination date:** 2020-09-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Foothill Ranch, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1000-2019

## Citation

> AI Analytics. FDA recall Z-1000-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1000-2019. Source: US FDA. Licensed CC0.

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