Trinity Non-Occluded Titanium Plasma Sprayed (Tps) Acetabular Shells

• • Terminated Z-2605-2021 FDA Class II ·initiated 28 Jul 2021 ·on shared 510(k) K123705

  The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

• 3 recalls, same reason

  • Terminated Z-1526-2016 FDA Class II ·initiated 29 Jan 2016
  • Terminated Z-1528-2016 FDA Class II ·initiated 29 Jan 2016
  • Terminated Z-1527-2016 FDA Class II ·initiated 29 Jan 2016

  Potential for abrasion of the sterile barrier pouches of the new packaging system.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K123705 ↗

FDA Product Code

LZO

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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