RecallRadar

FDA Device recall Z-2166-2012

Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: intend…

On 2012-08-15 the FDA classified a Class II recall of Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: intend… 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-2166-2012
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 two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 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: 50388181, 50389102, 50392406, 50394176, 50395679, 50395801, 50399411, 50400927, 50402475, 50403491, 504…Lot Numbers: 50388181, 50389102, 50392406, 50394176, 50395679, 50395801, 50399411, 50400927, 50402475, 50403491, 50407007, 50410403, 50412883, 50414234, 50415663, 50416800, 50418329, 50419173, 50421006, 50422555

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-2166-2012%22

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