Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19222 |
| Brand Name: | DePuy Synthes Pedicle Awls, technique guides & outer labels |
| Model: | 036.000.216, 036.001.185, 388.550, 388.656 |
| Affected: | All |
| Software version: | |
| Recalling Organisation: | Johnson & Johnson (NZ) Limited 13a Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 922 638 |
| Manufacturer: | Synthes GmbH |
| Issue: | The echnique Guides for the systems mentioned above describe the Pedicle Awls as 4.0mm for use with screws (4.0mm - 7.0mm). These awls should be used with 5.0mm - 7.0mm screws. Action is being taken to communicate changes being made to Technique Guides and outer labels in order to clarify the intended use of these two awls within these systems. There has been no change to the design or manufacture of the Pedicle Awls. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 9/10/2015 |
