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Stryker Orthopaedics Restoration Gap Plate Screw recallZ-2135-2009 · 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-2135-2009
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 20 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: 2080-0020; GAP PLATE SCREWS T0WMKE 01-Jul-2013 GAP PLATE SCREWS T0XMKE 02-Jul-2013 GAP PLATE SCREWS T10MKE 02-Jul-2013 GAP PLATE SCREWS T0YMKE 02-Jul-2013 GAP PLATE SCREWS 22RMLE 07-Jul-2013 GAP PLATE SCREWS 229MLE 07-Jul-2013 GAP PLATE SCREWS 22PMLE 08-Jul-2013 GAP PLATE SCREWS D01MLE 21-Jul-2013 GAP PLATE SCREWS AYYMLE 23-Jul-2013 GAP PLATE SCREWS PLAMME 27-Aug-2013 GAP PLATE SCREWS PN2MME 27-Aug-2013 GAP PLATE SCREWS PL8MME 28-Aug-2013 GAP PLATE SCREWS PL9MME 28-Aug-2013 GAP PLATE SCREWS PN1MME 28-Aug-2013 GAP PLATE SCREWS 7DXMNE 16-Sep-2013 GAP PLATE SCREWS MET9H4 18-Dec-2013 GAP PLATE SCREWS MET9X8 18-Dec-2013 GAP PLATE SCREWS MET9X7 22-Dec-2013 GAP PLATE SCREWS METL9Y 28-Dec-2013 GAP PLATE SCREWS METLA0 30-Dec-2013 GAP PLATE SCREWS MET9H5 30-Dec-2013 GAP PLATE SCREWS MET9X9 30-Dec-2013 GAP PLATE SCREWS MET9XA 30-Dec-2013 GAP PLATE SCREWS MHA4YT 14-Jan-2014 GAP PLATE SCREWS MHA4YR 18-Jan-2014 GAP PLATE SCREWS MHA55K 18-Jan-2014 GAP PLATE SCREWS MHA55L 18-Jan-2014 GAP PLATE SCREWS MHA55H 18-Jan-2014

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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