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FDA Medical Device Recalls (openFDA)

Smith & Nephew, Inc., Endoscopy Div.: Smith & Nephew Drill, 2.7mm for BioRaptor Suture Anchor (non-sterile) Reference Number: 7210430

Recall number
Z-0371-06
Recalling firm
Smith & Nephew, Inc., Endoscopy Div.
Product
Smith & Nephew Drill, 2.7mm for BioRaptor Suture Anchor (non-sterile) Reference Number: 7210430
Status
Terminated
Initiated
2005-07-01
Posted
2006-01-11
Terminated
2016-09-27
Reason
Drill does not contain laser etched depth marks to assure proper depth of inserted device
Root cause
Other
Action
Smith & Nephew notified accounts by Federal Express 07/01/2005 . Accounts are requested tor return units. Sales representatives notified by email.
Quantity
4 units
Distribution
NC, PR
Lot, serial or model codes
Lot Number: 50102446
510(k) numbers
not on file
PMA numbers
not on file
Product code
LXH
Firm FEI
1219602
Firm city
Mansfield
Firm state
MA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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