DePuy Synthes Radiolucent Retractor — Class II medical device recall Z-0092-2015
Terminated recall by Synthes, Inc., reported 2014-10-29, distributed in MI, NC, NY, PA, TN, WA, WI. Particle residue on the instrument from adhesive tape which was used to bind the device during transport. Ther
| Recall number | Z-0092-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-10-02 |
| Classified | 2014-10-20 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2015-12-18 |
| Distributed | MI, NC, NY, PA, TN, WA, WI |
| Quantity | 11 |
| Lot numbers | 3620715 |
| Model numbers | 387.580 |
Product
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0092-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.