Recall Z-2220-2013
Smith & Nephew, Inc. Endoscopy Division · initiated August 6, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 Biodegradable suture anchor
Codes / lots: 50261071 50265227 50268236 50270124 50270127 50270731 50270732 50270944 50272331 50272463 50272751 50274143 50274349 50277106 50278834 50281659 50282211 50282825 50283848 50285062 50287130 50288422 50289369 50291056 50292247 50293722 50295044 50295954 50297046 50298435 50299024 50301146 50301385 50302078 50306608 50307181 50307859 50308888 50308912 50309137 50311191 50312587 50314102 50315238 50316441 50316664 50317482 50317875 50318971 50319908 50320248 50321101 50321648 50322088 50322930 50323639 50324385 50325610 50325737 50326879 50327995 50328245 50329009 50329813 50330435 50332245 50333093 50333956 50334115 50334402 50335321 50336229 50336882 50337043 50337449 50338243 50338995 50339833 50340161 50341063 50341287 50341846 50342910 50343441 50344016 50344263 50344619 50346628 50347009 50347537 50348331 50349439 50350189 50350979 50351681 50351959 50352540 50353155 50353497 50353607 50354099 50355298 50355824 50356121 50356985 50357105 50357560 50358205 50358555 50359713 50360281 50360451 50361177 50362090 50362645 50362978 50363189 50363545 50364184 50364663 50364910 50364911 50364912 50369681 50369960 50370096 50370209 50371913 50373322 50373580 50374378 50375175 50375582…
Reason for recall
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
FDA-determined cause: Packaging
Action taken
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.
Details
- Recall number
- Z-2220-2013
- Initiated
- August 6, 2013
- Posted by FDA
- September 17, 2013
- Terminated
- April 20, 2016
- Product code
- JDR – Staple, Fixation, Bone
- Quantity
- 25733
- 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…
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division, Andover, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2215-2013 Class II | BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2216-2013 Class II | BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2217-2013 Class II | BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2218-2013 Class II | BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2219-2013 Class II | BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2221-2013 Class II | OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2222-2013 Class II | OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2223-2013 Class II | OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2224-2013 Class II | OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2225-2013 Class II | OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2226-2013 Class II | OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2227-2013 Class II | OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2228-2013 Class II | OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2229-2013 Class II | TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2230-2013 Class II | TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2231-2013 Class II | TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2232-2013 Class II | TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2233-2013 Class II | TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2234-2013 Class II | TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2235-2013 Class II | TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2236-2013 Class II | TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2237-2013 Class II | RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number:…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2238-2013 Class II | TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2239-2013 Class II | TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |
| Z-2240-2013 Class II | TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue…Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 08/06/2013Terminated |