Z-1712-2014Class II
PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument
Microport Orthopedics Inc. / initiated 2014-04-30 / Terminated / root cause: design
Microport Orthopedics INC. began a recall of PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument on . FDA classified it as Class II and gives the reason as "Difficulty removing the cup adaptor from the impaction handle during surgery". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1712-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Microport Orthopedics Inc.
- Product
- PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
- Product code
- LXH Orthopedic Manual Surgical Instrument
- Reason for recall
- Difficulty removing the cup adaptor from the impaction handle during surgery
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- 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.
- Quantity in commerce
- 140 units
- Distribution
- Nationwide Distribution.
- Product codes and lots
- Lot Number(s): 1153896, 1279714, 1288604, and 1314793
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1712-2014 | Class II | Terminated | Voluntary: Firm initiated |
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