Date Initiated by Firm | June 29, 2021 |
Date Posted | August 12, 2021 |
Recall Status1 |
Completed |
Recall Number | Z-2250-2021 |
Recall Event ID |
88259 |
510(K)Number | K050398 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
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Product | Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component. |
Code Information |
Serial Numbers: 6465589-6465618; 6465641 |
Recalling Firm/ Manufacturer |
Exactech, Inc. 2320 Nw 66th Ct Gainesville FL 32653-1630
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For Additional Information Contact | 352-377-1140 |
Manufacturer Reason for Recall | Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5). |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The firm notified their direct consignees on 06/29/2021 by email. The letter requested return of the affected devices. The firm will issue a letter through the sales representatives to the implanting physicians to follow-up with the patients beginning 07/23/2021. |
Quantity in Commerce | 29 devices |
Distribution | US Nationwide Distribution |
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.
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510(K) Database | 510(K)s with Product Code = LZO
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