Recall Z-0563-2020
Wright Medical Technology, Inc. · initiated November 8, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538
Codes / lots: Lot Number 1568030
Reason for recall
The firm discovered a lack of adequate documentation confirming sterility on certain products.
FDA-determined cause: Process control
Action taken
The firm initiated the recall on 11/08/2016 by letter and email to the user level. The firm requested the return of the units.
Details
- Recall number
- Z-0563-2020
- Initiated
- November 8, 2016
- Terminated
- November 3, 2020
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 40 units
- Distribution
- US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
- Recalling firm
- Wright Medical Technology, Inc., Arlington, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0562-2020 Class II | SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0564-2020 Class II | PRO-STIM 10cc INJECTABLE, Part Number 86SR0410The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0565-2020 Class II | INBONE STEM, TIBIAL, TOP, Part Number 200011901The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0566-2020 Class II | VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0567-2020 Class II | Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032SThe firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0568-2020 Class II | Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0569-2020 Class II | EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0570-2020 Class II | SWANSON FINGER JOINT #1, Part Number 4700001The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0571-2020 Class II | SWANSON FINGER JOINT #2, Part Number 4700002The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0572-2020 Class II | SWANSON TRAPEZIUM IMPLANT, Part Number 4520002The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0573-2020 Class II | CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |