RecallRadar

FDA Device recall Z-2168-2012

Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: in…

On 2012-08-15 the FDA classified a Class II recall of Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: in… by Smith And Nephew Endoscopy Division, citing distal part of the anchor may break on insertion into bone during surgery.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2168-2012
ClassificationClass II
Statusterminated
Initiated2012-07-03
Published2012-08-15
Last updated2026-09-13 11:53 UTC
CompanySmith And Nephew Endoscopy Division
DistributionUS

Product

Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: intended for use for the reattachment of soft tissue to bone

Reason

Distal part of the anchor may break on insertion into bone during surgery

Identifiers

code_info
Lot Numbers: 50388188, 50389268, 50392431, 50393764, 50394899, 50395675, 50396849, 50397464, 50398727, 50399817, 504…Lot Numbers: 50388188, 50389268, 50392431, 50393764, 50394899, 50395675, 50396849, 50397464, 50398727, 50399817, 50400184, 50402082, 50403278, 50405085, 50406197, 50406805, 50408994, 50410001, 50412043, 50412967, 50414260, 50415224, 50416542, 50415681, 50417216, 50418491, 50420660, 50421624

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2168-2012%22

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