FDA Enforcement
Class II
Terminated
Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants.
Recall: Z-1317-2014
·
Reported April 9, 2014
Enforcement
- Recall Number
- Z-1317-2014
- Event ID
- 67734
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Howmedica Osteonics Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 9, 2014
- Initiation Date
- February 3, 2014
- Classification Date
- April 2, 2014
- Termination Date
- December 2, 2014
- Address
- 325 Corporate Dr, N/A, Mahwah, NJ, 07430-2002, United States
Description
Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants.
Reason
Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem - Right Size #3.
Code Info
v40 Hip Stem -Right Size # 3: catalog # 6265-5113 lot code #43317101, v40 Hip Stem -Left Size # 4: catalog #6265-5104 lot code #43316801, lot code 43316901, v40 Hip Stem - Right Size #4: catalog #6265-5114 lot code #43113901
Distribution
USA Nationwide Distribution
Quantity
48 units