FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
- Recall number
- Z-1186-2021
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
- Status
- Terminated
- Initiated
- 2021-02-10
- Posted
- not on file
- Terminated
- 2023-05-30
- Reason
- Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.
- Root cause
- Under Investigation by firm
- Action
- On 2/11/2021, Stryker issued Urgent Medical Device Recall notices to customers via UPS 2-day air stating Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized.
- Quantity
- 11 devices
- Distribution
- Domestic: AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV.
- Lot, serial or model codes
- Catalogue # 5536-B-400, Lot Number CTD44301
- 510(k) numbers
- ["K123486","K141056"]
- PMA numbers
- not on file
- Product code
- MBH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28