| Date Initiated by Firm | September 05, 2023 |
|---|
| Date Posted | October 06, 2023 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0069-2024 |
|---|
| Recall Event ID |
93021 |
| Product Classification |
Dermatome - Product Code GFD
|
| Product | Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities
Part number: 00880000010 |
|---|
| Code Information |
FG (Blade) UDI:
(01)00889024375895(17)280205(10)65599469
(01)00889024375895(17)280206(10)65620875
(01)00889024375895(17)280207(10)65621233
(01)00889024375895(17)280209(10)65630969
(01)00889024375895(17)280212(10)65647382
(01)00889024375895(17)280213(10)65648460
(01)00889024375895(17)280214(10)65709066
(01)00889024375895(17)280219(10)65925347
(01)00889024375895(17)280220(10)65925348
(01)00889024375895(17)280221(10)65935737
(01)00889024375895(17)280223(10)65935738
(01)00889024375895(17)280319(10)65952857
(01)00889024375895(17)280424(10)65952858
(01)00889024375895(17)280430(10)65972711
(01)00889024375895(17)280503(10)65972712
(01)00889024375895(17)280507(10)65988623
(01)00889024375895(17)280426(10)65952862
(01)00889024375895(17)280509(10)65988624
(01)00889024375895(17)280514(10)65989036
(01)00889024375895(17)280516(10)65989037
(01)00889024375895(17)280520(10)66000975
(01)00889024375895(17)280523(10)66000976
(01)00889024375895(17)280528(10)66002852
(01)00889024375895(17)280530(10)65952860
(01)00889024375895(17)280610(10)66002853
(01)00889024375895(17)280613(10)66014333
(01)00889024375895(17)280617(10)66014332
(01)00889024375895(17)280624(10)66038885
(01)00889024375895(17)280628(10)66172214
(01)00889024375895(17)280710(10)66049031
(01)00889024375895(17)280724(10)66078057
(01)00889024375895(17)280719(10)66049032
Sales Unit (Box) UDI
(01)00889024380318(17)280205(10)65599469
(01)00889024380318(17)280206(10)65620875
(01)00889024380318(17)280207(10)65621233
(01)00889024380318(17)280209(10)65630969
(01)00889024380318(17)280212(10)65647382
(01)00889024380318(17)280213(10)65648460
(01)00889024380318(17)280214(10)65709066
(01)00889024380318(17)280219(10)65925347
(01)00889024380318(17)280220(10)65925348
(01)00889024380318(17)280221(10)65935737
(01)00889024380318(17)280223(10)65935738
(01)00889024380318(17)280319(10)65952857
(01)00889024380318(17)280424(10)65952858
(01)00889024380318(17)280430(10)65972711
(01)00889024380318(17)280503(10)65972712
(01)00889024380318(17)280507(10)65988623
(01)00889024380318(17)280426(10)65952862
(01)00889024380318(17)280509(10)65988624
(01)00889024380318(17)280514(10)65989036
(01)00889024380318(17)280516(10)65989037
(01)00889024380318(17)280520(10)66000975
(01)00889024380318(17)280523(10)66000976
(01)00889024380318(17)280528(10)66002852
(01)00889024380318(17)280530(10)65952860
(01)00889024380318(17)280610(10)66002853
(01)00889024380318(17)280613(10)66014333
(01)00889024380318(17)280617(10)66014332
(01)00889024380318(17)280624(10)66038885
(01)00889024380318(17)280628(10)66172214
(01)00889024380318(17)280710(10)66049031
(01)00889024380318(17)280724(10)66078057
(01)00889024380318(17)280719(10)66049032
Lot Numbers:
65599469
65620875
65621233
65630969
65647382
65648460
65709066
65925347
65925348
65935737
65935738
65952857
65952858
65972711
65972712
65988623
65952862
65988624
65989036
65989037
66000975
66000976
66002852
65952860
66002853
66014333
66014332
66038885
66172214
66049031
66078057
66049032
|
Recalling Firm/
Manufacturer |
Zimmer Surgical Inc
200 W Ohio Ave
Dover OH 44622-9642
|
| For Additional Information Contact | 411 Technical Services
574-371-3071 |
|---|
Manufacturer Reason
for Recall | Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | Zimmer issued Urgent Medical Device Recall Letter (FA 2023-00208 ) to Distributors and
Risk Managers and Recall FAQs to affected consignees on September 5, 2023. Letter states reason for recall, health risk and action to take:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, immediately locate and quarantine affected product in your inventory.
a. Your Zimmer Biomet sales representative may remove and return the affected product from your facility on your behalf.
b. Alternatively, you may directly return all affected product from your facility.
i. Complete Attachment 1 Certificate of Acknowledgement for each return and send to CorporateQuality.PostMarket@zimmerbiomet.com.
ii. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
iii. Mark RECALL on the outside of the returned cartons
3. If the product has been further distributed, provide your customers with the recall notice and ensure documentation.
4. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility. Upon receipt of affected product, Zimmer Biomet will credit your account. Please return a copy of the completed response form along with your returned product to ensure proper credit.
5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation.
6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimm |
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| Quantity in Commerce | 11,985 boxes (119,850 blades) |
|---|
| Distribution | US Nationwide
Foreign:
AUSTRALIA
BRAZIL
CHINA
HONG KONG
INDIA
JAPAN
MALAYSIA
MEXICO
NETHERLANDS
ON
SEOUL
SINGAPORE
TAIWAN
THAILAND
|
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
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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