| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01266-2 |
| Product Name/Description |
PFNA Nails (used during internal fixation surgery)
PFNA ø10 125° L240 TAN Part Number: 472.260S, Lot Number: 7913867
PFNA ø11 125° L240 TAN Part Number: 472.261S, Lot Number: 2812685
PFNA ø10 long r 125° L340 TAN Part Number: 472.275S, Lot Number: 2806520
ARTG Number: 161140 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
It was discovered that the above part and lot numbers may have the incorrect anodised colour. An implant with the incorrect anodised colour would not cause harm to the patient. If the user identifies the nonconformity during surgery, marginal surgical delay may occur while an alternate implant is located. |
| Recall Action |
Recall |
| Recall Action Instructions |
JJM is advising users to inspect and quarantine affected stock for return to JJM. This action has been closed-out on 05/09/2016. This action has been closed-out on 05/09/2016. |
| Contact Information |
1300 562 711 - Customer Service |