Recall Z-2246-2018 ยท FSM Tray, Surgical, Instrument
Synthes (USA) Products LLC
Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
| Date | Mar 5, 2018 |
| Status | Terminated |
| Reason | Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length. |
| Root cause | Process control |
| Action | On March 8, 2018, the recalling firm sent Urgent Product Recall letters to its customers to inform them of the recall. Customers were advised to take the following actions: 1. Immediately review their inventory to identify and quarantine all affected products listed above in a manner that ensures the affected products will not be used. 2. Complete the Verification Section and send a copy to the recalling firm. 3. Forward this notice to anyone in the facility that needs to be informed. 4. If any of the affected products have been forwarded to another facility, contact that facility to arrange r |
| Quantity | 4 |
| Distribution | Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.