| Date Initiated by Firm | June 26, 2009 |
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| Date Posted | September 14, 2009 |
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| Recall Status1 |
Terminated 3 on July 27, 2010 |
| Recall Number | Z-2160-2009 |
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| Recall Event ID |
52713 |
| 510(K)Number | K013106 |
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| Product Classification |
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
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| Product | Restoration Modular Hip System; Proximal Cone Body;
21 mm +0 mm (STD);
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss. |
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| Code Information |
Catalog number: 6276-1-021; REST MOD PROX CONE BODY 21mm +0mm (STD) 28733303 22-Jan-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28733303 22-Jan-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28733301 09-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28733301 09-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28733301 09-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28800301 09-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28800301 09-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847903 11-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847901 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847901 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847901 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847903 11-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847901 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847902 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847901 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847902 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847902 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847902 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847902 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28800302 17-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28800302 17-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28800302 17-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29299401 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29299401 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29299401 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358402 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29299402 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358402 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358402 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29476201 27-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29476201 27-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29492001 27-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358401 30-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358401 30-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358401 30-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29285601 31-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29524901 07-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29524901 07-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29421001 31-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29421001 31-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358401 30-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29285601 31-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29524901 07-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29524901 07-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29546101 08-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29546101 08-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29546101 08-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29546101 08-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29706302 21-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29706302 21-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29706302 21-Apr-2014 |
Recalling Firm/
Manufacturer |
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
|
| For Additional Information Contact | Colleen O'Meara
201-972-2100 |
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Manufacturer Reason
for Recall | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by this vendor has raised concern about their supplied raw material. As a precaution and due to the potential impact on the mechanical properties of the products, St |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| Action | 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. |
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| Quantity in Commerce | 203 - all varieties |
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| Distribution | Worldwide Distribution |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = LZO
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