Recalls / —
—#66604
Product
Hipstar TMZF Cementless Hip Stem Protocol, Product Number: LSP60.
- FDA product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- Affected lot / code info
- Literature # LPS60 (Lot code n/a)
Why it was recalled
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 (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2002
Distribution
- Distribution pattern
- Nationwide:The protocol was distributed to 9 Stryker branches/agencies in NJ, MD, IN, MI, MN, IL and TX.
Timeline
- Recall initiated
- 2007-09-28
- Posted by FDA
- 2007-12-14
- Terminated
- 2008-09-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #66604. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.