Recall Z-2777-2020 ยท LXH Orthopedic Manual Surgical Instrument
Smith & Nephew, Inc.
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus and clavicle.
| Date | Jun 29, 2020 |
| Status | Terminated |
| Reason | The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part. |
| Root cause | Process design |
| Action | The firm sent a letter to customers dated 06/29/2020 and titled "Urgent Medical Device Recall Notice". The letter informs customers of a field action to voluntarily remove a single lot of PeriLoc Targeters due to a manufacturing error. Customers should inspect their inventory and locate any devices from the listed product and batch numbers enclosed with the Recall Notice, and quarantine them immediately. Sales reps or distributors, should notify customers of the field action and ensure that the required actions are complete. Customers should completed a form identifying if they have product |
| Quantity | 3 units |
| Distribution | U.S Nationwide including in the states of IN and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.