PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
FDA device recall Z-1712-2014 · posted 2014-06-04 · Terminated
Recall details
- Recalling firm
- Microport Orthopedics INC.
- Reason for recall
- Difficulty removing the cup adaptor from the impaction handle during surgery
- Action taken
- Firm has initiated the recall by email on 04/28/2014 to all distributor's offices, including international, then followed with written communication on 05/02/2014 via Fed Ex P1 delivery to all United States consignees. Follow-up to non-responding consignees will commence 30 days after initiation.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 140 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-04-30
- Date posted
- 2014-06-04
- Date terminated
- 2014-12-01
- Location
- Arlington, TN
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