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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Tornier Perform

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 Class 2 Device Recall Stryker Tornier Performsee related information
Date Initiated by FirmAugust 29, 2024
Date PostedSeptember 27, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3309-2024
Recall Event ID 95245
510(K)NumberK201315 
Product Classification prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented - Product Code PAO
ProductStryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Code Information GTIN 00846832084494, Batch Lot # 1495AY
Recalling Firm/
Manufacturer		 Tornier, Inc
10801 Nesbitt Ave S
Bloomington MN 55437-3109
For Additional Information ContactMeghan Wells
901-201-9298
Manufacturer Reason
for Recall		Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
FDA Determined
Cause 2		Under Investigation by firm
ActionStryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via email. The notice explained the issue, potential risk, and requested the following actions be taken: Identify and isolate the affected units, and respond to the notice via email. Upon receipt of the response, Stryker will arrange for the return of the device. Those consignees who further distributed the product (to other sites or customers) were directed to notify those parties. For questions or concerns, contact: memphis.fieldaction@stryker.com.
Quantity in Commerce38 units
DistributionUS Nationwide distribution.
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 = PAO
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