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Stryker Orthopaedics Restoration Gap Plate Screw recallZ-2138-2009 · Stryker Howmedica Osteonics Corp. · initiated Jun 26, 2009

Terminated All recalls posted in September 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.

Recall details

Recall number
Z-2138-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 26, 2009
Posted by the FDA
Sep 14, 2009
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
51,113 total - all sizes.
Product code
MEH
FDA submissions
K873251
Distribution
Worldwide Distribution

Product description

Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 35 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Catalog number: 2080-0035; GAP PLATE SCREWS PTJMKE 29-Jun-2013 GAP PLATE SCREWS PTLMKE 29-Jun-2013 GAP PLATE SCREWS T0RMKE 06-Jul-2013 GAP PLATE SCREWS T0PMKE 06-Jul-2013 GAP PLATE SCREWS T0VMKE 06-Jul-2013 GAP PLATE SCREWS J47MLE 21-Jul-2013 GAP PLATE SCREWS J44MLE 21-Jul-2013 GAP PLATE SCREWS J45MLE 22-Jul-2013 GAP PLATE SCREWS J48MLE 22-Jul-2013 GAP PLATE SCREWS 4P9MNE 10-Sep-2013 GAP PLATE SCREWS 4PDMNE 11-Sep-2013 GAP PLATE SCREWS 4PAMNE 11-Sep-2013 GAP PLATE SCREWS 4P8MNE 11-Sep-2013 GAP PLATE SCREWS MERN4W 05-Dec-2013 GAP PLATE SCREWS MERN4X 05-Dec-2013 GAP PLATE SCREWS METD97 21-Dec-2013 GAP PLATE SCREWS METDE0 21-Dec-2013 GAP PLATE SCREWS METDDX 21-Dec-2013 GAP PLATE SCREWS METDE3 21-Dec-2013 GAP PLATE SCREWS METDE6 21-Dec-2013 GAP PLATE SCREWS METDE2 30-Dec-2013

Other devices under the same FDA submission

7 devices cleared under K873251 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 52713).

Sources and updates

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