# FDA recall Z-0997-2019

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

## Product

Ossur Skull Pin, Sterile Titanium Pin,    Part/Description:   516TS/ Skull Pin 2-1/4in TI Sterl 1PK;  516V2S/ Skull Pin 3in TI Sterl 1PK;  520TS/ Skull Pin 2-1/4in TI Sterl 5PK;  520V2S/ Skull Pin 3in TI Sterl 5 PK

## 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-0997-2019
- **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-0997-2019

## Citation

> AI Analytics. FDA recall Z-0997-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0997-2019. Source: US FDA. Licensed CC0.

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