Lower risk Medical device recall · FDA · Published June 21, 2018

Ossur Skull Pin Recall: Incorrect Ceramic Tip Label on Titanium Pins

Ossur recalls specific skull pins due to a label error listing ceramic tip instead of titanium. Affected products were sold from June 2009 to December 2018. Correct label should state titanium pin.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0997-2019Medical device Ossur ›

Lower-risk 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.

Take action

Contact the company

Recalling firmOssur Americas27051 Towne Centre Dr · Foothill Ranch, CA 92610-2804

✎ GovInfoNow plain-language explainer

Ossur is recalling certain skull pins that have a label error showing a ceramic tip instead of titanium. This mistake could confuse users about the pin's material, but it does not pose a safety risk. Read more at govinfonow.com/recall/70774-ossur-skull-pin-recall-incorrect-ceramic-tip-label-on-titanium.

Source Summary by GovInfoNow · govinfonow.com/recall/70774-ossur-skull-pin-recall-incorrect-ceramic-tip-label-on-titanium · Updated August 21, 2026 · FDA enforcement record: FDA #Z-0997-2019

Cite this page

“Ossur Skull Pin Recall: Incorrect Ceramic Tip Label on Titanium Pins.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70774-ossur-skull-pin-recall-incorrect-ceramic-tip-label-on-titanium. Based on FDA recall #Z-0997-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0997-2019%22&limit=1).

The Food and Drug Administration announced on June 21, 2018, that Ossur Americas is recalling Ossur Skull Pin sterile titanium pins due to labeling errors. The hazard involves products labeled MR conditional undergoing confirmatory safety testing and labels mistakenly listing a ceramic tip instead of a titanium pin.

How to tell if you have it

Brand: Ossur
Product: Ossur Skull Pin, Sterile Titanium Pin
Part Numbers: 516TS, 516V2S, 520TS, 520V2S
Lot Codes: AL18021418, AL17022109, AL18021417, AL15091012
Manufacturing Dates: 06/30/2009 - 12/13/2018

The hazard

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

Context

GovInfoNow's records show Ossur Americas has four other recalls on record since June 1, 2021. On August 29, 2022, the company recalled Power Knee units because the battery may dislodge. Other recent recalls of similar products include Olymp Inner Sheath 21 Fr Model A2660T (November 11, 2025) and Olympus Resection Sheath (November 11, 2025), both citing ceramic tip breakage risk.

How to tell if you have this one

Check for part numbers 516TS, 520TS, 516V2S, or 520V2S with production dates from June 30, 2009, to December 13, 2018. The label should correctly state 'titanium pin' instead of 'ceramic tip'.

Brand
Ossur
Category
Medical device

FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
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

Recall number	Product, codes & lots	Quantity
Z-0997-2019	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; All lots of the products manufactured from 06/30/2009 - 12/13/2018 Titanium Pin Label Mistakenly lists Ceramic Tip, Part/Lot numbers: 516TS/ AL18021418 and AL17022109; 520TS/ AL18021417 and AL15091012	372
Z-0998-2019	Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK; 516DS/ Skull Pin 3in CT Sterl 1PK; 517CS/ Skull Pin 2-1/4in CT Sterl 4PK; 517DS/ Skull Pin 3in CT Sterl 4 PK; 522CS/ Skull Pin 2-1/4in CT Sterl 6PK; 522C/ SKULL PIN 2-1/4 CT 6 PK; All lots of the products manufactured from 06/30/2009 - 12/13/2018	824
Z-0999-2019	Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ OB RESOLVE RING KIT STD; 505500D/ OB RESOLVE RING KIT LRG; 515300D/ OB RESOLVE RING KIT SM-No App; 515400D/ OB RESOLVE RING KIT STD-No App; 515500D/ OB RESOLVE RING KIT LG-No App; 540D/ OB RESOLVE COMPONENT TRAY; All lots of the products manufactured from 06/30/2009 - 12/13/2018	342
Z-1000-2019	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; All lots of the products manufactured from 06/30/2009 - 12/13/2018	656
Z-1001-2019	Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT TI SM; 505400T/ CB RING KIT TI STD; 505400V2/ OB V2 RING KIT TI STD; 505500T/ CB RING KIT TI LG; 505500V2/ OB V2 RING KIT TI LG; 515300V2/ OB V2 RING KIT TI SM-No App; 515400V2/ OB V2 RING KIT TI STD-No App; 515500T/ CB RING KIT TI LG-No App; 515500V2/ OB V2 RING KIT TI LG-No App; 515300T/ CB RING KIT TI SM-No App; 515400T/ CB RING KIT TI STD-No App; 515301T/ CB RING KIT TI SM 8-No APP; 515301V2/ OB V2 RING KIT TI SM 8-No App; 515401T/ CB RING KIT TI STD 8-No APP; 515401V2/ OB V2 RING KIT TI STD 8-No APP; 515501T/ CB RING KIT TI LG 8-No App; 515501V2/ OB V2 RING KIT TI LG 8-No App; 540T/ STERILE TITANIUM COMP TRAY; 540V2/ STERILE V2 COMPONENT TRAY; All lots of the products manufactured from 06/30/2009 - 12/13/2018	182
Z-1002-2019	Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY; All lots of the products manufactured from 06/30/2009 - 12/13/2018	138
Z-1003-2019	Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ ReSolve Halo Vest-shrt lmbwool; 545800K/ ReSolve Halo Vest-tall kodel; 545800L/ ReSolve Halo Vest-tall lmbwool; All lots of the products manufactured from 06/30/2009 - 12/13/2018	381
Z-1004-2019	Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; 545100L/ LIL ANGEL VEST P2 LAMBSWOOL; 545100S/ LIL ANGEL VEST P2 SORBATEX; 545150K/ LIL ANGEL VEST P3 KODEL; 545150L/ LIL ANGEL VEST P3 LAMBSWOOL; 545150S/ LIL ANGEL VEST P3 SORBATEX; All lots of the products manufactured from 06/30/2009 - 12/13/2018	45

Based on the official FDA remedy

What to do — step by step

Check Label
Look for the label that says 'titanium pin' instead of 'ceramic tip' on the product.

Where it went and when

Where it was distributed

Distributed in 28 states, and outside the U.S.

FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Jun 21, 2018Firm started the recall
Mar 11, 2019FDA classified it Class II
Mar 20, 2019Published in FDA’s Enforcement Report
Sep 4, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/70774-ossur-skull-pin-recall-incorrect-ceramic-tip-label-on-titanium">Ossur Skull Pin Recall: Incorrect Ceramic Tip Label on Titanium Pins (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0997-2019 (June 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0997-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.