FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Hipstar TMZF Cementless Hip Stem Protocol, Product Number: LSP60.
- Recall number
- Z-0475-2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Hipstar TMZF Cementless Hip Stem Protocol, Product Number: LSP60.
- Status
- Terminated
- Initiated
- 2007-09-28
- Posted
- 2007-12-14
- Terminated
- 2008-09-05
- Reason
- Mis-labeling: An error on page 4 of the Hipstar protocol was found. In the table for compatible Heads, the 40 mm diameter heads with a Neck Length of +12 should have been omitted.
- Root cause
- Other
- Action
- Urgent Product Correction Letters, dated 10/17/2007 were sent on 10/17/07by Federal Express to all Stryker Branches/Agencies who had received the protocol. The branches were instructed to quarantine and destroy the protocols.
- Quantity
- 192 protocols
- Distribution
- Nationwide:The protocol was distributed to 9 Stryker branches/agencies in NJ, MD, IN, MI, MN, IL and TX.
- Lot, serial or model codes
- Literature # LPS60 (Lot code n/a)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LPH
- 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