FDA Device recall Z-0092-2015
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
- FDA Device
- Class II
- terminated
- Published 2014-10-29
On 2014-10-29 the FDA classified a Class II recall of DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715 by Synthes, citing 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 p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0092-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-02 |
| Published | 2014-10-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | MI, NC, NY, PA, TN, WA, WI |
Product
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
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.
Identifiers
| code_info | Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0092-2015%22
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