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U.S. Department of Health and Human Services

Class 2 Device Recall Screw, Fixation, Bone, Dynanail Hybrid

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 Class 2 Device Recall Screw, Fixation, Bone, Dynanail Hybridsee related information
Date Initiated by FirmNovember 17, 2021
Create DateJanuary 04, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0453-2022
Recall Event ID 89117
510(K)NumberK203381 
Product Classification Screw, fixation, bone - Product Code HWC
ProductDYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Code Information Model No. 2600-05-006; Lot No. 04882; UDI: M97026000500060
FEI Number 3007593722
Recalling Firm/
Manufacturer		 Medshape, INC.
1575 Northside Dr Nw Ste 440
Atlanta GA 30318-4211
For Additional Information ContactJason Whyte
678-235-3314
Manufacturer Reason
for Recall		The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure.
FDA Determined
Cause 2		Device Design
ActionThe firm indicated that they will send recall notification to sales representatives via email or certified mail. Customers will be instructed to remove all +6 mm endcaps from stock and to return to the recalling firm with a return label that will be provided at a later date. Customers with questions are to contact the recalling firm at (678)235-3314.
Quantity in Commerce26 units (1 count)
DistributionDomestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = HWC
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