Recalls / —
—#160095
Product
smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
- FDA product code
- HRS — Plate, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K140814
- Affected lot / code info
- 17AM14602
Why it was recalled
One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
Root cause (FDA determination)
Employee error
Action the firm took
Smith & Nephew Inc. initiated its recall by email on November 29, 2017. The consignee was directed to return the recalled product. For further questions, please call (901) 396-2121.
Recalling firm
- Firm
- Smith & Nephew, Inc.
- Address
- 1450 E Brooks Rd, Memphis, Tennessee 38116-1804
Distribution
- Distribution pattern
- US Distribution to the state of OR, and Internationally to Colombia.
Timeline
- Recall initiated
- 2017-11-29
- Terminated
- 2020-09-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #160095. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.