Z-0082-2012

Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360

Name: Z-0082-2012 Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2011-09-23
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2011-09-23 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage: Endoscope & Accessories on 2011-09-23. The reason FDA records is "HD1200 camera heads may cause image issues". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0082-2012
Status: Terminated
Initiated: 2011-09-23
Posted: 2011-10-21
Terminated: 2016-02-16
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage: Endoscope & Accessories
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: HD1200 camera heads may cause image issues
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Smith Nephew sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated sent September 23, 2011 to all affected consignees. The letter identified the product, problem and actions to be taken. Consignees were instructed to complete requested information, return affected product and order replacement product. To return product and order replacement product, consignees were instructed to contact the Smith & Nephew Endoscopy Returns Group at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to [email protected]. For questions call 405-917-8556.
Quantity in commerce: 15 units
Distribution: Nationwide Distribution (USA) including the states of: MI, NH, OK.
Product codes and lots: S/N: DDQ00051, DDQ00052, DDQ00057 DDQ00064, DDQ00068, DDQ00070 DDQ00071, DDQ00080, DDQ00083 DDQ00085, DDQ00093, DDQ00094 DDQ00096, DDQ00104, DDQ00108

Product code GCJ

K014158Class IIEndoscopic Camera Tc804/c4World of Medicine Lemke GmbH / cleared 2002-03-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)