Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes… — Class II medical device recall Z-0387-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-12-04, distributed in AR, AZ, CA, CO, GA, IL, IN, MI…. The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the comp
| Recall number | Z-0387-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2013-07-31 |
| Classified | 2013-11-25 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2015-06-01 |
| Distributed | AR, AZ, CA, CO, GA, IL, IN, MI, MS, NY, PA, TN, TX, VA |
| Quantity | 135 |
| Lot numbers | 5734551, 6083065, 6538811, 6631975, 6703190, 6703191, 6841538, SD357.371 |
| Model numbers | 5734551, 6083065, 6538811, 6631975, 6703190, 6703191, 6841538, SD357.371 |
Product
Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.
Reason for recall
The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.
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-0387-2014. 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.