Recall Z-0809-2016— Exactech, Inc.

Name: FDA recall Z-0809-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-28

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2015-09-28, terminated 2017-03-01. It names one FDA 510(k) clearance: K132582. Product: Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach.. Reason: Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody Fusion Device Lordotic (05-090-01-1610) were packaged as Acapella One Interbody Fusion Device Parallel (05-090-02-1610).

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-09-28
Terminated: 2017-03-01
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K132582 — EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEMExactech, Inc.·cleared 2014-02-12

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

Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach.

Reason for recall

Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody Fusion Device Lordotic (05-090-01-1610) were packaged as Acapella One Interbody Fusion Device Parallel (05-090-02-1610)

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