Recall Z-0092-2015 ยท GAD Retractor
Synthes, Inc.
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
| Date | Oct 20, 2014 (initiated Oct 2, 2014) |
| Status | Terminated |
| Reason | Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy. |
| Root cause | Material/Component Contamination |
| Action | DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated October 2, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please take the following actions: If you DO have any of the identified devices, please take the following steps: Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices fou |
| Quantity | 11 |
| Distribution | US Distribution including the states of PA, NC, TN, NY, WI, WA and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.