Ossur Skull Pin — Class II medical device recall Z-0997-2019
Terminated recall by Ossur Americas, reported 2019-03-20, distributed in AK, AL, AZ, CA, DE, FL, GA, HI…. Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional
| Recall number | Z-0997-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ossur Americas, Foothill Ranch, CA, United States |
| Recall initiated | 2018-06-21 |
| Classified | 2019-03-11 |
| Reported by FDA | 2019-03-20 |
| Terminated | 2020-09-04 |
| Distributed | AK, AL, AZ, CA, DE, FL, GA, HI, IL, IN, KY, MA, MI, MN, MS, NC, NE, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WA |
| Countries outside the US | AU, BE, DE, NZ |
| Quantity | 372 |
| Reason classes | labeling |
| Lot numbers | 516TS, 520TS, AL15091012, AL17022109, AL18021417, AL18021418 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0997-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.