510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1958-2009

Stryker Reflex Hybrid Level Anterior Cervical Plate; Non Sterile; Manufactured by Stryker Spine SAS, Cestas...

Howmedica Osteonics Corp / initiated 2006-06-14 / Terminated / root cause: design
FDA source (opens on fda.gov)

Stryker Spine began a recall of Stryker Reflex Hybrid Level Anterior Cervical Plate; Non Sterile; Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp... on . The reason FDA records is "Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1958-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Howmedica Osteonics Corp
Product
Stryker Reflex Hybrid Level Anterior Cervical Plate; Non Sterile; Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp. Mahwah, NJ 07430.
Product code
KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall
Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.
Root cause tag
design
FDA root cause
Device Design
Action
Stryker Spine issued an "Important Market Withdrawal" notice dated June 14, 2006. Consignees were advised to complete and return a Product Accountability Form via fax to 1-201-831-6069 prior to returning the affected product. Product return was to be performed during certain phase periods when upgrades were being shipped. For further questions, contact Stryker Spine at 1-201-831-5825.
Quantity in commerce
38987 plates
Distribution
Nationwide Distribution -- Including states of NC, OR, AZ, TN, CA, MA, MD, IL, GA, FL, NJ, NM, KY, LA, PA, MI, UT, MO, OK, KS, OH, MN, NE, IN, MT, TX, AL, CO and WI.
Product codes and lots
All Product with the following Catalog Number/Description: 48650112, Reflex Hybrid one-level plate, size 12mm; 48650114m size 14 mm; 48650116, 16 mm; 48650118, size 18mm; 48650120, size 20 mm; 48650122, size 22 mm.  48650224, Reflex Hybrid Two-Level Plate, size 24 mm; 48650226, size 26 mm; 48650228, size 28 mm; 48650230, size 30 mm; 48650232, size 32 mm; 48650234, size 34 mm; 48650237, size 37 mm; 48650240, size 40 mm; 48650243, size 43 mm; 48650246, size 46 mm. 48650339, REflex Hybrid Three-Level Plate, Size 39 mm; 48650342, size 42mm; 48650345, suze 45 mm; 48650348, size 48 mm; 48650351, size 51 mm; 48650354, size 54 mm; 48650357, size 57 mm; 48650360, size 60 mm; 48650363, size 63 mm; 48650366, size 66 mm; 48650369, size 69 mm. 48650460, Reflex Hybrid four-Level Plate, size 60 mm; 48650464, size 64 mm; 48650468, size 68 mm; 48650472, size 72 mm; 48650476, size 76 mm; 48650489, size 80 mm; 48650484, size 84 mm.