Z-0880-2008

Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following...

Name: Z-0880-2008 Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following...
Creator: Abbott Spine
Published: 2007-12-19
License: https://open.fda.gov/license/

Spinal Concepts, Inc. / initiated 2007-12-19 / Terminated / root cause: design

FDA source

Abbott Spine began a recall of Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following consignment surgical kits: Harmony 2700-0001-PL... on 2007-12-19. The reason FDA records is "Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0880-2008
Status: Terminated
Initiated: 2007-12-19
Posted: 2008-02-13
Terminated: 2010-10-04
Recalling firm: Spinal Concepts, Inc.
Product: Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following consignment surgical kits: Harmony 2700-0001-PL, Harmony 2700-0009-PL, Harmony 2900-0001-PL, Harmony 2900-0002-PL, Cadence 1500-0002-PL and Cadence 1500-0008-PL; Distributed by Abbott Spine, Austin, TX 78727.
Product code: GZT Retractor, Self-Retaining, For Neurosurgery
Reason for recall: Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use.
Root cause tag: design
FDA root cause: Device Design
Action: All medical suppliers with consigned inventory from affected lots were contacted via phone beginning 12/19/07. Consignees notified of potential issue and were asked to inspect their inventory and contact Abbott Spine for return and replacement of the affected handles.
Quantity in commerce: 230 handles.
Distribution: Worldwide:Medical suppliers in the following states: AR, AZ, CA, CT, FL, IL, LA, MD, MI, MO, MN, NC, NJ, NM, NV, OH, OK, OR, PA, TX, VA and WI. and country of Spain.
Product codes and lots: Lot Numbers: 13ZD, 14KC, 21NJ, 29XC, 36TP, 38AE, 39NN, 43CC, 43SW, 45KK, and 46WK.

Product code GZT

K050706Class IIHarmony Port System, Model 1907 SeriesSpinal Concepts, Inc. / cleared 2005-04-15

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)