| | Class 2 Device Recall Bigliani/Flatow |  |
| Date Initiated by Firm | August 23, 2005 |
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| Date Posted | October 07, 2005 |
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| Recall Status1 |
Terminated 3 on December 08, 2005 |
| Recall Number | Z-0023-06 |
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| Recall Event ID |
33279 |
| 510(K)Number | K022377 K031449 |
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| Product Classification |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented - Product Code KWS
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| Product | Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000. |
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| Code Information |
All lots. |
Recalling Firm/
Manufacturer |
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
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| For Additional Information Contact |
800-846-4637 |
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Manufacturer Reason
for Recall | The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement. |
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FDA Determined
Cause 2 | Other |
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| Action | Consignees were notified via letter dated August 23, 2005 or by email. |
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| Distribution | Nationwide, Australia, Canada, England, Germany and Italy. |
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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 = KWS
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