Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 8 mm diameter, 130 mm length, non-sterile, catalog no. 43
FDA device recall Z-1271-06 · posted 2006-07-27 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal.
- Action taken
- U.S. and international distributors were notified of the recall via letter dated 6/30/2006 to check customer inventories and to return recalled product to the firm. Trial implants were redesigned and reworked to eliminate the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- HWT
- Quantity affected
- 324 total
- Distribution
- Nationwide and worldwide including Australia, Canada, Germany, Italy and Spain.
- Date initiated
- 2006-06-16
- Date posted
- 2006-07-27
- Date terminated
- 2007-12-05
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.