IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.
FDA device recall Z-1704-2009 · posted 2009-08-04 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- Incorrect depth gauge mark etched onto guide wire pin. Guide pin is too long.
- Action taken
- Urgent Medical Device Recall letter dated January 23, 2009. All affected Smith & Nephew Sales Representatives, Distributors and Hospitals were notified of problem and the recall via Fed Ex and e-mail on 01/22/2009. They were instructed to immediately check their inventory and return the product.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 99 units
- Distribution
- Distribution to USA, Switzerland and Australia.
- Date initiated
- 2009-01-22
- Date posted
- 2009-08-04
- Date terminated
- 2011-08-18
- Location
- Memphis, TN
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