Z-0884-2020Class II

Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm

Name: Z-0884-2020 Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm
Creator: Brasseler USA I Lp
Published: 2019-12-11
License: https://open.fda.gov/license/

Brasseler USA I, L.P. / initiated 2019-12-11 / Terminated / root cause: labeling and UDI

FDA source

Brasseler USA I Lp began a recall of 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... on 2019-12-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0884-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-11
Posted: 2020-01-29
Terminated: 2021-02-12
Recalling firm: Brasseler USA I, L.P.
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.
Product code: HTY Pin, Fixation, Smooth
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 56 packs of 6
Distribution: US: AZ, AR, FL
Product codes and lots: Lot Number NR8ZR

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0884-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0884-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29

Product code HTY

K945670Class IIKirschner (K-Wire), Steinman PinsBrasseler USA I, L.P. / cleared 1995-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)