—#93718

Product

Omnifit M/S PSL Porous Coated Acetabular Shell 48MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis.

FDA product code: MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K912654
Affected lot / code info: Catalog number 2017-0048, Lot # 4S3088, 5H3020A, 6H3068, 7M3050A, 7M3050D, 7S3048, 8K3108, 8M3034, 8M3034A, 8N3045, 8N3045A.

Why it was recalled

Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.

Root cause (FDA determination)

Device Design

Action the firm took

The firm, Stryker Orthopaedics, sent an "URGENT PRODUCT RECALL" letter dated August 2, 2010, via Federal Express to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory to identify the affected product; retrieve all affected product and return it their branch or agency warehouse for reconciliation; reconcile all product(s) on the attached Product Recall Acknowledgement Form and fax to (201) 831-6069, and return the affected product via Inter-Org Transfer and ship to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Worldwide distribution: USA including states of: AL, AR, CA, FL, IN, ME, MI, MS, NC, NJ, OK, OR, WA , and WI; and countries including: China, Hong Kong and Korea.

Timeline

Recall initiated: 2010-08-02
Posted by FDA: 2011-02-07
Terminated: 2012-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93718. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.