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. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
- Recall number
- Z-1366-2009
- 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. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
- 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
- 6021-0435 ACCOLADE (127 DEG) SIZE 4 24884802 6021-0435 ACCOLADE (127 DEG) SIZE 4 24918803 6021-0435 ACCOLADE (127 DEG) SIZE 4 25045801 6021-0435 ACCOLADE (127 DEG) SIZE 4 25045802 6021-0435 ACCOLADE (127 DEG) SIZE 4 25069801 6021-0435 ACCOLADE (127 DEG) SIZE 4 25080502 6021-0435 ACCOLADE (127 DEG) SIZE 4 25094901 6021-0435 ACCOLADE (127 DEG) SIZE 4 25108901 6021-0435 ACCOLADE (127 DEG) SIZE 4 25138302 6021-0435 ACCOLADE (127 DEG) SIZE 4 25179401 6021-0435 ACCOLADE (127 DEG) SIZE 4 25211501 6021-0435 ACCOLADE (127 DEG) SIZE 4 25231401 6021-0435 ACCOLADE (127 DEG) SIZE 4 25255902 6021-0435 ACCOLADE (127 DEG) SIZE 4 25311401 6021-0435 ACCOLADE (127 DEG) SIZE 4 25311402 6021-0435 ACCOLADE (127 DEG) SIZE 4 25337801 6021-0435 ACCOLADE (127 DEG) SIZE 4 25400803 and 6021-0435 ACCOLADE (127 DEG) SIZE 4 25515602.
- 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