Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
- Recall Initiated
- January 21, 2016
- Posted
- February 25, 2016
- Terminated
- June 8, 2017
- Recall Number
- Z-0873-2016
- Quantity
- 147,838 units in total
- Firm Location
- Mahwah, NJ
Reason for Recall
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Distribution
US Nationwide Distribution
Lot / Code Info
Catalog number 1806-0050S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Root Cause
Under Investigation by firm
Action Taken
Stryker Orthopaedics sent an Urgent Medical Device Removal letter and Customer Response forms dated January 21, 2016 through UPS. The letter identified the affected product, problem, actions to be taken including forwarding notice if applicable, returning all affected products and completing and returning the Customer Response form to Stericycle.by the instructions provided.
More recalls by Stryker Howmedica Osteonics Corp.
Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131...
Apr 26, 2017
Reunion TSA Peg Alignment Sound
Catalog #5901-1038
The Peg Alignment Sound (PIN 5901-1038, Revision...
Dec 2, 2016
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-...
Nov 9, 2016