| Class 2 Device Recall Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock | |
Date Initiated by Firm | June 23, 2016 |
Create Date | August 11, 2016 |
Recall Status1 |
Terminated 3 on August 01, 2018 |
Recall Number | Z-2390-2016 |
Recall Event ID |
74619 |
510(K)Number | K123486 |
Product Classification |
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
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Product | Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile,
Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants |
Code Information |
Catalog No: I-K3254TA00 Lot Nos: F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099 and F7L16994 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2006
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For Additional Information Contact | Mr. Michael Van Ryn 201-831-5000 |
Manufacturer Reason for Recall | It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing. |
FDA Determined Cause 2 | Process control |
Action | Stryker sent an Urgent Product Recall letter dated June 24, 2016, with a Business Reply Form attached to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to inform users of the Urgent Product Recall letter and forward the notice to all those individuals who need to be aware within their organization. Customers were instructed to return all affected product at their location to:
Stryker C/O Stericycle
2670 Executive Dr., Suite A
Indianapolis, IN 46241
Customers were also instructed to complete and sign the enclosed Business Reply Form and fax it to 888-912-7352 or email to Stericycle at strykerortho4582@stericycle.com. Customers with questions were advised to call (201) 831-6693.
For questions regarding this recall call 201-831-5000. |
Quantity in Commerce | 47 units |
Distribution | Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MBH
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