| Date Initiated by Firm | May 02, 2025 |
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| Date Posted | July 08, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2099-2025 |
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| Recall Event ID |
96894 |
| 510(K)Number | K234056 |
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| Product Classification |
Implantable post-surgical kinematic measurement knee device - Product Code QPP
|
| Product | Brand Name: Canturio Smart Extension
Product Name: CSE Implant
Model/Catalog Number: 43-5570-030-14
Product Description: Tibial stem extension for use with Zimmer Persona Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually.
Component: Yes. The Canturio Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona Personalized Knee System. |
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| Code Information |
Lot Code: Model No: 43-5570-030-14UDI-DI
(GTIN): 00860003118399
Lot Numbers: AJ327, AJ330, AJ592
Serial Numbers: Provided in Attachment
Lot Numbers / CSE Serial Numbers / UDI code:
AJ327 30939 (01)00860003118399(17)270228(21)030939
AJ327 30972 (01)00860003118399(17)270228(21)030972
AJ592 31048 (01)00860003118399(17)270228(21)031048
AJ592 31050 (01)00860003118399(17)270228(21)031050
AJ592 31053 (01)00860003118399(17)270228(21)031053
AJ592 31064 (01)00860003118399(17)270228(21)031064
AJ592 31083 (01)00860003118399(17)270228(21)031083
AJ592 31088 (01)00860003118399(17)270228(21)031088
AJ592 31090 (01)00860003118399(17)270228(21)031090
AJ592 31093 (01)00860003118399(17)270228(21)031093
AJ592 31095 (01)00860003118399(17)270228(21)031095
AJ592 31096 (01)00860003118399(17)270228(21)031096
AJ592 31098 (01)00860003118399(17)270228(21)031098
AJ592 31102 (01)00860003118399(17)270228(21)031102
AJ592 31104 (01)00860003118399(17)270228(21)031104
AJ592 31120 (01)00860003118399(17)270228(21)031120
AJ592 31121 (01)00860003118399(17)270228(21)031121
AJ592 31129 (01)00860003118399(17)270228(21)031129
AJ592 31168 (01)00860003118399(17)270228(21)031168
AJ592 31277 (01)00860003118399(17)270228(21)031277
AJ592 31370 (01)00860003118399(17)270228(21)031370
AJ592 31412 (01)00860003118399(17)270228(21)031412
AJ592 31415 (01)00860003118399(17)270228(21)031415
AJ592 31429 (01)00860003118399(17)270228(21)031429
AJ592 31439 (01)00860003118399(17)270228(21)031439
AJ592 31449 (01)00860003118399(17)270228(21)031449
AJ592 31470 (01)00860003118399(17)270228(21)031470
AJ592 31474 (01)00860003118399(17)270228(21)031474
AJ592 31482 (01)00860003118399(17)270228(21)031482
AJ592 31489 (01)00860003118399(17)270228(21)031489
AJ592 31493 (01)00860003118399(17)270228(21)031493
AJ592 31498 (01)00860003118399(17)270228(21)031498
AJ592 31515 (01)00860003118399(17)270228(21)031515
AJ592 31517 (01)00860003118399(17)270228(21)031517
AJ592 31529 (01)00860003118399(17)270228(21)031529
AJ592 31530 (01)00860003118399(17)270228(21)031530
AJ592 31531 (01)00860003118399(17)270228(21)031531
AJ592 31534 (01)00860003118399(17)270228(21)031534
AJ592 31540 (01)00860003118399(17)270228(21)031540
AJ592 31542 (01)00860003118399(17)270228(21)031542
AJ592 31552 (01)00860003118399(17)270228(21)031552
AJ592 31554 (01)00860003118399(17)270228(21)031554
AJ592 31558 (01)00860003118399(17)270228(21)031558
AJ592 31560 (01)00860003118399(17)270228(21)031560
AJ592 31564 (01)00860003118399(17)270228(21)031564
AJ592 31569 (01)00860003118399(17)270228(21)031569
AJ592 31573 (01)00860003118399(17)270228(21)031573
AJ592 31574 (01)00860003118399(17)270228(21)031574
AJ592 31593 (01)00860003118399(17)270228(21)031593
AJ592 31598 (01)00860003118399(17)270228(21)031598
AJ592 31599 (01)00860003118399(17)270228(21)031599
AJ592 31607 (01)00860003118399(17)270228(21)031607
AJ592 31613 (01)00860003118399(17)270228(21)031613
AJ592 31620 (01)00860003118399(17)270228(21)031620
AJ592 31641 (01)00860003118399(17)270228(21)031641
AJ592 31645 (01)00860003118399(17)270228(21)031645
AJ592 31649 (01)00860003118399(17)270228(21)031649
AJ592 31662 (01)00860003118399(17)270228(21)031662
AJ592 31748 (01)00860003118399(17)270228(21)031748
AJ592 31750 (01)00860003118399(17)270228(21)031750
AJ592 31759 (01)00860003118399(17)270228(21)031759
AJ592 31774 (01)00860003118399(17)270228(21)031774
AJ592 31806 (01)00860003118399(17)270228(21)031806
AJ592 31814 (01)00860003118399(17)270228(21)031814
AJ592 31824 (01)00860003118399(17)270228(21)031824
AJ592 31866 (01)00860003118399(17)270228(21)031866
AJ592 31868 (01)00860003118399(17)270228(21)031868
AJ592 31872 (01)00860003118399(17)270228(21)031872
AJ592 31891 (01)00860003118399(17)270228(21)031891
AJ592 31893 (01)00860003118399(17)270228(21)031893
AJ592 31903 (01)00860003118399(17)270228(21)031903
AJ592 31905 (01)00860003118399(17)270228(21)031905
AJ592 31917 (01)00860003118399(17)270228(21)031917
AJ592 31951 (01)00860003118399(17)270228(21)031951
AJ592 31953 (01)00860003118399(17)270228(21)031953
AJ330 30873 (01)00860003118399(17)270228(21)030873
AJ330 30892 (01)00860003118399(17)270228(21)030892
AJ330 30920 (01)00860003118399(17)270228(21)030920
AJ330 30921 (01)00860003118399(17)270228(21)030921
AJ330 30932 (01)00860003118399(17)270228(21)030932
AJ330 30949 (01)00860003118399(17)270228(21)030949
AJ330 30966 (01)00860003118399(17)270228(21)030966
AJ330 30984 (01)00860003118399(17)270228(21)030984
AJ330 31018 (01)00860003118399(17)270228(21)031018
AJ330 31028 (01)00860003118399(17)270228(21)031028
AJ330 31041 (01)00860003118399(17)270228(21)031041
AJ330 31114 (01)00860003118399(17)270228(21)031114
AJ330 31122 (01)00860003118399(17)270228(21)031122
AJ330 31152 (01)00860003118399(17)270228(21)031152
AJ330 31161 (01)00860003118399(17)270228(21)031161
AJ330 31171 (01)00860003118399(17)270228(21)031171
AJ330 31182 (01)00860003118399(17)270228(21)031182
AJ330 31195 (01)00860003118399(17)270228(21)031195
AJ330 31197 (01)00860003118399(17)270228(21)031197
AJ330 31198 (01)00860003118399(17)270228(21)031198
AJ330 31209 (01)00860003118399(17)270228(21)031209
AJ330 31216 (01)00860003118399(17)270228(21)031216
AJ330 31258 (01)00860003118399(17)270228(21)031258
AJ330 31269 (01)00860003118399(17)270228(21)031269
AJ330 31327 (01)00860003118399(17)270228(21)031327
AJ330 31355 (01)00860003118399(17)270228(21)031355
AJ330 31371 (01)00860003118399(17)270228(21)031371
AJ330 31376 (01)00860003118399(17)270228(21)031376
AJ330 31440 (01)00860003118399(17)270228(21)031440
AJ330 31819 (01)00860003118399(17)270228(21)031819
AJ330 31862 (01)00860003118399(17)270228(21)031862 |
Recalling Firm/
Manufacturer |
Canary Medical, Inc.
2710 Loker Ave W Ste 350
Carlsbad CA 92010-6645
|
Manufacturer Reason
for Recall | Due to labeling error. Product incorrectly labeled. |
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FDA Determined
Cause 2 | Process change control |
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| Action | On 05/09/2025, the firm sent via email an "URGENT: Medical Device Field Action Notification" Letter dated 5/5/2025. This letter describes the product, problem and actions to be taken.
Customers are instructed to:
1.Retrieve all affected units in storage or distribution and return to Canary Medical at
9315 Winnetka Ave N Suite 300
Brooklyn Park, MN, 55445
Attn: Gina Brownfield
2.Review your sales records and identify if any Affected Product has been distributed to your customers and complete Appendix 1 form Notification to Customers in the Medical Device Recall Response Form attached. Sign the completed Medical Device Recall Response Form return it via coroorateQuality.PostMarket@zimmerbiomet.com or fax to 574-373-3589 or 574-372-4011.
For questions or assistance - contact Customer Service at:
Phone: 1-833-692-2627
Email: support@canarymedical.com
Mail: Canary Medical USA LLC 2710 Loker Ave. West, Suite 350
Carlsbad, CA 92010 USA |
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| Quantity in Commerce | 106 |
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| Distribution | US Distribution to IN only.
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = QPP
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