Recall Z-0393-2014 ยท LXH Orthopedic Manual Surgical Instrument
Synthes USA HQ, Inc.
Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant.
| Date | Nov 26, 2013 (initiated Oct 15, 2013) |
| Status | Terminated |
| Reason | One material batch used for production of the affected parts of the Synthes Material Mix were mixed in with an incorrect material with a lower than specified hardness and corrosion resistance. |
| Root cause | Nonconforming Material/Component |
| Action | SYNTHES sent an Urgent Notice: Medical Device Recall letter dated October 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product was located. Customers were also asked to indicate the number of devices found and note the Return Authorization Number. Return the Verification Form with the product to: |
| Quantity | approximately 44 |
| Distribution | Worldwided Distribution: USA (nationwide) including IL, MO, TX, WA and Internationally to Canada and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.