Home / Recalls / Ossur Americas / Z-0997-2019

Z-0997-2019 Class II Terminated

Recalled by Ossur Americas — Foothill Ranch, CA

Recall Details

Product Type
Devices
Report Date
March 20, 2019
Initiation Date
June 21, 2018
Termination Date
September 4, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
372

Product Description

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 Pattern

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

Code Information

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

Other recalls by Ossur Americas

  • Z-1821-2022 Class II — OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Kn (August 29, 2022)
  • Z-1330-2022 Class II — OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for childre (May 30, 2022)
  • Z-0380-2022 Class II — Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR- (November 9, 2021)
  • Z-1896-2021 Class II — OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobi (June 1, 2021)
  • Z-1001-2019 Class II — Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ O (June 21, 2018)
  • Z-1004-2019 Class II — Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; (June 21, 2018)
  • Z-0999-2019 Class II — Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE R (June 21, 2018)
  • Z-1002-2019 Class II — Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; (June 21, 2018)
  • Z-1000-2019 Class II — Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE U (June 21, 2018)
  • Z-0998-2019 Class II — Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull P (June 21, 2018)