Z-2218-2013Class II

BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable...

Name: Z-2218-2013 BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable...
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2013-08-06
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2013-08-06 / Terminated / root cause: packaging

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor on 2013-08-06. FDA classified it as Class II and gives the reason as "Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2218-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-06
Posted: 2013-09-17
Terminated: 2016-04-20
Recalling firm: Smith & Nephew, Inc.
Product: BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor
Product code: HWC Screw, Fixation, Bone
Reason for recall: Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Root cause tag: packaging
FDA root cause: Packaging
Action: Smith&Nephew sent an Urgent Product Recall Notification letter dated August 6, 2013, via Federal Express to all affected customers. Addendum customer letters for 4 additional part numbers were sent via Federal Express on August 19, 2013, The letters identified the product, the problem, and the action to be taken by the customer. Customers were asked to inspect their inventory, locate unused devices and quarantine them. Customers were also asked to complete the last three columns in the inventory Return Certification form indicating the quantities that need to be returned, and include their contact information in the spaces provided. Customers were instructed to contact Smith & Nephew's Demo Service Departmentat 800-343-5717 for a Return Authorization (RA#), and provide the information response form. Replacement product would be provided. For questions regarding this recall call 978-749-1073.
Quantity in commerce: 725 US
Distribution: Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
Product codes and lots: 50253115 50253116 50253563 50258921 50259836 50261046 50261482 50266078 50266098 50266396 50266957 50270377 50271281 50273022 50274567 50281658 50291542 50293283 50298902 50302160 50304442 50308346 50310770 50323628 50328862 50348760 50349091 50350411 50353298 50359945 50360003 50361170 50361752 50364587 50366305 50380819 50382582 50386154 50387219 50387852 50388184 50388737 50389115 50389772 50417524 50452589 50464571

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2218-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2215-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2216-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2217-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2218-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2219-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2220-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2221-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2222-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2223-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2224-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2225-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2226-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2227-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2228-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2229-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2230-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2231-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2232-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2233-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2234-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2235-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2236-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2237-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2238-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2239-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17
Z-2240-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17

Product code HWC

K031685Class IITag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. / cleared 2003-07-01

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)