Z-0592-2015Class II
PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina...
Stryker Corp. / initiated 2014-11-17 / Terminated / root cause: labeling and UDI
Stryker Endoscopy began a recall of PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China... on . FDA classified it as Class II and gives the reason as "The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0592-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Corp.
- Product
- PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Venezuela
- Product code
- KOG
- Reason for recall
- The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
- Root cause tag
- labeling and UDI
- FDA root cause
- Error in labeling
- Action
- Stryker Endoscopy sent an Urgent Device Correction letter dated November 17, 2014, to affected customers. The letter informed the customers of the potential hazards and actions required. Customers were instructed to discard any old Instructions for Use for their Laparoscopic Manual Instruments and Accessories. Download the new Instuctions for Use (IFU1000-401-070 Revision J) from the URL link below: www.stryker.com/IFU1000401070 Customers were instructed to complete and sign the enclosed "Acknowledgement of Receipt" form and email them to [email protected] or fax to (408) 855-6314. Customers with questions were instructed to contact Stryker Endoscopy at 408-855-6238 or via email at [email protected]. For questions regarding this recall call 408-754-2000.
- Quantity in commerce
- 180,573 units total
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
- Product codes and lots
- Serial/Lot 0915269/0817086 1015777 1016562/1015776 111333/1015777 111333-1015777
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0592-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0593-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0594-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0595-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0596-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0597-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0598-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0599-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0600-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0601-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0602-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0603-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0604-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0605-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0606-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0607-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0608-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0609-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0610-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0611-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0612-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0613-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0614-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0615-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0616-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0617-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0618-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0619-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0620-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0621-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0622-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0623-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0624-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0625-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0626-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0627-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0628-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0629-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0630-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0631-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0632-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0633-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0634-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0635-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0636-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0637-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0638-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0639-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0640-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0641-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0642-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0643-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0644-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0645-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0646-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0647-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0648-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0649-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0650-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0651-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0652-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0653-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0654-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0655-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0656-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0657-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0658-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0659-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0660-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0661-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0662-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0663-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0664-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0665-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0666-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0667-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0668-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0669-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0670-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0671-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0672-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0673-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0674-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0675-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0676-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0677-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0678-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0679-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0680-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0681-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0682-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0683-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0684-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0685-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0686-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0687-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0688-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0689-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0690-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0691-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0692-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0693-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0694-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0695-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0696-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0697-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0698-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0699-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0700-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0701-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0702-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0703-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0704-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0705-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0706-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0707-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0708-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0709-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0710-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0711-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0712-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0713-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0714-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0715-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0716-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0717-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0718-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0719-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0720-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0721-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0722-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0723-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0724-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0725-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0726-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0727-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0728-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0729-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0730-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0731-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0732-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0733-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0734-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0735-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0736-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0737-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0738-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0739-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0740-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0741-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0742-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0743-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0744-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0745-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0746-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0747-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0748-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0749-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0750-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0751-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0752-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0753-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0754-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0755-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0756-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0757-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0758-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0759-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0760-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0761-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0762-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0763-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0764-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0765-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0766-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0767-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0768-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0769-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0770-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0771-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0772-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0773-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0774-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0775-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0776-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0777-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0778-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0779-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0780-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0781-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0782-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0783-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0784-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0785-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0786-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0787-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0788-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0789-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0790-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0791-2015 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.