Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long — Class II medical device recall Z-2418-2015
Terminated recall by Synthes (USA) Products LLC, reported 2015-08-26, distributed nationwide. Potential for micropores to form, allowing fluid to enter the hollow handle.
| Recall number | Z-2418-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2015-07-29 |
| Classified | 2015-08-19 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2016-05-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,113 |
| Lot numbers | 5001180, 5001181, 5001182, 5001183, 5042920, 5042921, 5042922, 5042923, 5043720, 5043721, 5043722, 5043723, 5056224, 5056410, 5056411, 5056851, 5087081, 5087082, 5101097, 5106064, 5109323, 5109324, 5109325, 5109326, 5109327, 5162012, 5162016, 5207917, 5207918, 5252353, 5252354, 5252394, 5256421, 5256479, 5256480, 5303914, 5303916, 5305758, 5305759, 5305760 and 74 more |
| Model numbers | 03.100.013, 03.100.014 |
Product
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
Reason for recall
Potential for micropores to form, allowing fluid to enter the hollow handle.
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-2418-2015. 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.