Recall Z-0099-2023 ยท JDR Staple, Fixation, Bone
Synthes (USA) Products LLC
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
| Date | Oct 18, 2022 (initiated Sep 27, 2022) |
| Status | Open, Classified |
| Reason | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit. |
| Root cause | Error in labeling |
| Action | On September 27, 2022, the firm notified affected customers via urgent medical Device Recall letters. Customers were instructed to examine their inventory to determine if they have affected product and to quarantine them immediately - Customers should not use the recalled products. Customers should contact their DePuy Synthes Sales Consultant or call the customer support services at ra-dpyus-csspecial@its.jnj.com to coordinate the return/credits of the subject products. |
| Quantity | 94 US; 30 OUS |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142292 | Speed, Speed Shift, Speed Titan, Speed Arc Biomedical Enterprises, Inc., Nov 17, 2014 |