—#177408

Product

Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K121308
Affected lot / code info: Lot Number: G6091225, Exp. Date: 2022-06 UDIs: (01)04546540167712(17)220618(10)

Why it was recalled

Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)

Root cause (FDA determination)

Employee error

Action the firm took

Stryker issued An Urgent Field Safety Notice (FSN), PFA 2197654, was issued to all affected OUS consignees at country level on October 03, 2019. Action to take: Actions to be taken by the Customer/ User: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. A response is required, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Complete customer response form and return the form and any affected devices to the following address. (Please complete this form regardless of whether your organization has product to return. This will preclude the need for Stryker to send any reminder notice.) ATTN: David Nihill, Limerick Finished Goods Centre C/O Flextronics Global Services Ireland Unit 1 Raheen Business Park Raheen, Limerick.

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: Foreign: Australia, France, Finland, Germany, Italy, Japan, New Zealand, Netherlands, Norway, Romania, Spain, Sweden and UK

Timeline

Recall initiated: 2019-10-03
Terminated: 2022-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177408. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.