SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
Howmedica Osteonics Corp. · Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impa…
Open FDA's page for this record- Cfres ID
- 205139
- Product res number
- Z-0876-2024
- Event date initiated
- 2023-12-01
- Event date posted
- 2024-01-31
- Recall status
- Open, Classified
- Res event number
- 93687
- Product code
- JWH
- Product description
- SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
- Code info
- GTIN: 07613327034363 Lot Numbers: H43RDK, WR1RE3, 768NEY, 4J13P1
- Firm FEI number
- 3003070421
- Recalling firm
- Howmedica Osteonics Corp.
- Address 1
- 325 Corporate Dr
- City
- Mahwah
- State
- NJ
- Postal code
- 07430-2006
- Additional info contact
- Loriann Russo 201-831-5000
- Root cause description
- Nonconforming Material/Component
- Reason for recall
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Action
Stryker issued Urgent Medical Device Recall Letter (Product Field Action #: 3306872)through third party Sedgwick via UPS on 12/1/23. Letter states reason for recall, health risk and action to take: Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the affected product in Part/Lot Number Attachment: PFA 3306872 starting on page 3. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to strykerortho4367@sedgwick.com 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return ALL affected product to: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3306872; Please include Tracking information on the package. If you have any questions or concerns after reviewing this letter, please contact Customer Service at (201) 831-5000. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
- Distribution pattern
Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
- K numbers
- K994128
- Harmonized identifiers (openFDA)
- Device name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3560
- Device class
- 2
- K number
- K131019, K954138, K983835, K894937, K983004, K062274, K930554, K971550, K932776, K220737, K101994, K140555, K244039, K963255, K980925, K230537, K103117, K915132, K873197, K021740, K222380, K925072, K162222, K030686, K203447, K143047, K020383, K032606, K193105, K910992, K180159, K893762, K023788, K202429, K011643, K021451, K090705, K053579, K152169, K012348 +882 more
- Registration number
- 3006563559, 3009923578, 8010379, 3011061242, 3008985661, 3009590742, 3009971621, 3042508254, 3010009693, 3012392319, 3008421730, 3003639920, 1450662, 2528981, 9610612, 2133928, 1000200989, 3004513872, 3005551626, 3030412764, 3027484613, 3010123256, 3002808022, 3015516266, 1000286794, 1825034, 3008868758, 3010163695, 2249697, 3033509898, 1424263, 3007420745, 2245304, 1220477, 3012523063, 3008102042, 3009173317, 3005360851, 3048147961, 1832228 +282 more
- FEI number
- 3002807036, 3006563559, 3009923578, 3011061242, 3008985661, 3009590742, 1000086912, 3009971621, 3042508254, 3010009693, 3012392319, 3008421730, 1000221916, 3003639920, 1450662, 2528981, 3002287318, 1000200989, 3004513872, 3010938185, 3005551626, 3000717902, 3000717687, 3002806534, 3030412764, 3027484613, 3010123256, 3002808022, 3015516266, 1000136269, 1000286794, 3003574398, 1825034, 3008868758, 3010163695, 3033509898, 3007420745, 2245304, 1220477, 3012523063 +282 more
