Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth — Class II medical device recall Z-0884-2020
Terminated recall by Brasseler USA I Lp, reported 2020-02-05, distributed in AR, AZ, FL. 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth S
| Recall number | Z-0884-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brasseler USA I Lp, Savannah, GA, United States |
| Recall initiated | 2019-12-11 |
| Classified | 2020-01-29 |
| Reported by FDA | 2020-02-05 |
| Terminated | 2021-02-12 |
| Distributed | AR, AZ, FL |
| Reason classes | labeling |
| Lot numbers | NR8ZR |
Product
Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.
Reason for recall
103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins.
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-0884-2020. 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.