VKS Tibial Trial, Right/Left, Prep Guide; Model Number: 1214331, 1214332, 1214333, 1214334, 1214335: ( Model Number: 121
FDA device recall Z-0362-2008 · posted 2007-12-08 · Terminated
Recall details
- Recalling firm
- Plus Orthopedics USA
- Reason for recall
- The VKS "Tibial Trial" was found to have an incorrect fixation pin hole diameter.
- Action taken
- The initial depth of the withdrawal action taken November 2006 was to the distributor (agent) level. On 11/27/2006 Plus Orthopedics USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA. Agents were notified by telephone to check their inventory and return any affected units. A telephone script was used.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 19
- Distribution
- Nationwide to : AZ, CA, CO, FL, ID, NE, NY, SC, TX, UT, VA, and WA
- Date initiated
- 2006-11-27
- Date posted
- 2007-12-08
- Date terminated
- 2007-12-13
- Location
- San Diego, CA
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