Recall Z-2784-2016— The Anspach Effort, Inc.

Name: FDA recall Z-2784-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-24

Class I · Terminated

Class I FDA medical device recall by The Anspach Effort, Inc., initiated 2016-06-24, terminated 2018-06-09. It names one FDA 510(k) clearance: K043310. Product: Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone. The Adaptors (05.001.024 and 05.001.108) can be used with one of the electrical consoles belonging to the Electric Pen Drive (EPD) to operate the Small Battery Drive and Small Battery Drive II.. Reason: There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst..

Recalling firm: The Anspach Effort, Inc.
Classification: Class I
Status: Terminated
Initiated: 2016-06-24
Terminated: 2018-06-09
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K043310 — SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)·cleared 2005-01-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone. The Adaptors (05.001.024 and 05.001.108) can be used with one of the electrical consoles belonging to the Electric Pen Drive (EPD) to operate the Small Battery Drive and Small Battery Drive II.

Reason for recall

There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.

Data sourced from openFDA. This site is unofficial and independent of the FDA.