FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
- Recall number
- Z-0656-2013
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
- Status
- Terminated
- Initiated
- 2012-10-23
- Posted
- 2013-01-08
- Terminated
- 2013-09-11
- Reason
- Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.
- Root cause
- Labeling mix-ups
- Action
- Stryker sent "Urgent Medical Device Recall Notification" letters and product accountability forms via Fed Ex with return receipt on 10/23/12 to branches/agencies and to hospitals and physicians on 10/24/12. The letter described the issue and provided recommended actions to mitigate the risk. Customers can call (201) 972-2100 if questions.
- Quantity
- 6021-2530- four units; 6021-3535-
- Distribution
- Nationwide distribution, including the states of NY, NJ, CA and FL.
- Lot, serial or model codes
- Catalog Number: 6021-2530 Lot #40264005 Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US.
- 510(k) numbers
- ["K994366"]
- PMA numbers
- not on file
- Product code
- MEH
- 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