Z-2219-2013Class II

BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor

Name: Z-2219-2013 BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor
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, pack of 1 ULTRABRAID Suture: 72200689 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-2219-2013
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, pack of 1 ULTRABRAID Suture: 72200689 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: 240 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: 50257249 50266395 50266956 50273021 50274566 50292663 50298060 50310769 50312085 50312489 50314911 50319308 50320226 50365776 50366000 50372062 50372899 50373577 50430178 50430381 50432333 50433339 50435314 50437523

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2219-2013
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)