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Terminated

TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039, 71325040, 71325041,71325042, 71325043, 71325044, 71325045, 71325046, 71325047, 71325048, 71325049, 71325050, 71325051, 71325052, 71325053, 71325054, 71325055, 71325057, 71372047

FDA Recall Z-0351-2017 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeKWY
Date Initiated2016-08-29
Date Terminated2019-08-16
Product Quantity5806 units

Reason for Recall

Some Bipolar shells were manufactured with an out of specification retainer groove.

Firm Action

The firm initiated their recall by FedEx and Email on 08/29/2016 to hospitals and distributors and requested the return of any in stock product. International consignees were notified by Email on 08/29/2016. Additionally, the firm notified the US physician of the issue by overnight letter on 09/08/2016.

Root Cause

Process control

Distribution Pattern

Nationwide and Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023743SMITH & NEPHEW GLOBAL BIPOLAR SYSTEMSmith & Nephew, Inc. · 2003-01-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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