| Date Initiated by Firm | December 03, 2013 |
|---|
| Date Posted | January 07, 2015 |
|---|
| Recall Status1 |
Terminated 3 on September 29, 2016 |
| Recall Number | Z-0936-2015 |
|---|
| Recall Event ID |
69422 |
| 510(K)Number | K896553 |
|---|
| Product Classification |
System, isokinetic testing and evaluation - Product Code IKK
|
| Product | Cervical Extension Machine
for Physical Therapy |
|---|
| Code Information |
Serial Numbers: 02511166, 02511167, 02511171, 02511170. |
| FEI Number |
1051095
|
Recalling Firm/
Manufacturer |
MedX Holdings, Inc.
839 Nw 25th Ave
Ocala FL 34475-5789
|
| For Additional Information Contact | Linda Polk
352-351-2005 |
|---|
Manufacturer Reason
for Recall | Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing. |
|---|
FDA Determined
Cause 2 | Unknown/Undetermined by firm |
|---|
| Action | Medx began contacting its consignees December 30, 2013, to schedule testing on the devices at their facility. The technician has been scheduled to complete required testing of these devices in the field.
For questions regarding this recall call 322-351-2005. |
|---|
| Quantity in Commerce | 4 |
|---|
| Distribution | Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = IKK
|
|---|
