Biomet RINGLOC + Instrumentation Impactor Plate, Size 26; REF/Part#: 31-400626, Biomet Orthopedics, Inc., Warsaw, IN.
FDA device recall Z-0704-2008 · posted 2008-02-05 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The instrument will not lock onto the impactor handle; the device was distributed without assembly of the Bal Seal component.
- Action taken
- Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 141 total for all recalls Z-0700-0705-2008
- Distribution
- Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.
- Date initiated
- 2007-10-18
- Date posted
- 2008-02-05
- Date terminated
- 2008-03-11
- Location
- Warsaw, IN
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