ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 0022530574
FDA device recall Z-1681-2016 · posted 2016-05-16 · Terminated
Recall details
- Recalling firm
- Zimmer Manufacturing B.V.
- Reason for recall
- A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Action taken
- All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 50
- Distribution
- Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
- Date initiated
- 2016-05-04
- Date posted
- 2016-05-16
- Date terminated
- 2017-07-05
- Location
- Mercedita, PR
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ITST Intertrochanteric/Subtrochanteric Fixation System (K143321) | Zimmer, Inc. | 2015-05-29 |