Hipstar TMZF Cementless Hip Stem Protocol, Product Number: LSP60.
FDA device recall Z-0475-2008 · posted 2007-12-14 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 192 protocols
- Distribution
- Nationwide:The protocol was distributed to 9 Stryker branches/agencies in NJ, MD, IN, MI, MN, IL and TX.
- Date initiated
- 2007-09-28
- Date posted
- 2007-12-14
- Date terminated
- 2008-09-05
- Location
- Mahwah, NJ
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