FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle.
- Recall number
- Z-1372-2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle.
- Status
- Terminated
- Initiated
- 2009-01-06
- Posted
- 2009-07-22
- Terminated
- 2012-06-25
- Reason
- Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Root cause
- Process control
- Action
- An "Urgent Product Recall" letter was sent via Federal Express on January 6, 2009 with return receipt to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter described the affected product, issue, potential hazards and risks. Stryker Branches and Hospital Risk Management were asked to examine their inventory for affected product. Stryker Representatives were instructed to contact customers to reconcile and return recalled product to Stryker Orthopaedics. All letters include a response form to be completed and returned indicating that they have been informed of the recall and the amount of product on hand, if any. Direct questions about the recall to Stryker Orthopaedics at 1-201-831-5718.
- Quantity
- 1,628 total stems, all varieties.
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 24956301 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 24973501 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25025502 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25025503 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25109103 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25169701 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25190701 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25244401 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25338602 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25372501 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25427901and 6021-4535 ACCOLADE (127 DEG) SIZE 4.5 25445501.
- 510(k) numbers
- ["K023102"]
- 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