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.
FDA Recall Z-0884-2020 · Posted None
Advertisement
Recalling FirmBrasseler USA I Lp
Recall StatusTerminated
Product CodeHTY
Date Initiated2019-12-11
Date Terminated2021-02-12
Product Quantity56 packs of 6
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.
Firm Action
Initial contact to affected consignees was made on 12/11/2019 by telephone to provide notification of the labeling error and arrange for replacement product. Recall letter also sent to affected consignees.
Root Cause
Labeling mix-ups
Distribution Pattern
US: AZ, AR, FL
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement