Recall Z-1821-2013 ยท LXH Orthopedic Manual Surgical Instrument
Synthes USA HQ, Inc.
Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Deg
| Date | Jul 29, 2013 (initiated Oct 12, 2012) |
| Status | Terminated |
| Reason | A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18mm drill guide. The firm identified that this constituted a field action and retrospectively reported this action. |
| Root cause | Labeling Change Control |
| Action | The firm, Synthes USA, sent an email to its customer. The email identified the product, problem and the actions to be taken. The customer was instructed to do the following: do not use this product; do not remove any product from your account or return any product without further instructions. If you have identified that you have the product, please have the product located in an area that ensures it will not be used. Further instructions will be sent out with regards to any action that needs to be taken next. Please call Synthes if you have any questions at 610-719-5364. |
| Quantity | 2 |
| Distribution | US distribution: PA only. . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.