MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
FDA device recall Z-1487-2017 · posted 2017-03-20 · Terminated
Recall details
- Recalling firm
- Crossroads Extremity Systems Llc
- Reason for recall
- Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.
- Action taken
- The firm notified their distributors by email on 02/16-17/2017. The distributors were asked to return the unused lot #101866. The firm also contacted the implanting surgeons either by visit or telephone about the potential for an incorrect size of the implant and asked if there were any adverse events.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JDR
- Quantity affected
- 20 units
- Distribution
- Al, FL, IN, Il, NE, TX, NM, CO, AZ
- Date initiated
- 2017-02-16
- Date posted
- 2017-03-20
- Date terminated
- 2017-04-27
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CrossCLIP Implant System (K142727) | Orthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems | 2014-10-24 |