FDA Medical Device Recalls (openFDA)
Crossroads Extremity Systems Llc: MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
- Recall number
- Z-1487-2017
- Recalling firm
- Crossroads Extremity Systems Llc
- Product
- MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
- Status
- Terminated
- Initiated
- 2017-02-16
- Posted
- 2017-03-20
- Terminated
- 2017-04-27
- Reason
- Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.
- Root cause
- Labeling mix-ups
- Action
- 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.
- Quantity
- 20 units
- Distribution
- Al, FL, IN, Il, NE, TX, NM, CO, AZ
- Lot, serial or model codes
- Lot Number 101868
- 510(k) numbers
- ["K142727"]
- PMA numbers
- not on file
- Product code
- JDR
- Firm FEI
- 3020584246
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28