Biomet brand Modular Microplasty Cup Impactor, 3/8" - 24 Thread Insert; Model 31-400603. Instrument for hip prosthesis a
FDA device recall Z-1186-2008 · posted 2008-08-20 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The weld at the lock location may fracture during impaction.
- Action taken
- Biomet notified distributors and medical facilities by letter dated 1/16/08. Distributors with distributor-owned instruments at medical facilities were notified by email on 1/17/08, and provided with a letter to present to their associated medical facilities describing the recall.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 59
- Distribution
- Worldwide Distribution: USA, Germany, Mexico, Netherlands, Sweden and United Kingdom.
- Date initiated
- 2008-01-16
- Date posted
- 2008-08-20
- Date terminated
- 2009-09-22
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.