Device Recall Stryker Orthopaedics Restoration Gap Plate Screw

Catalog number: 2080-0015; GAP PLATE SCREWS D36MLE 18-Jul-2013 GAP PLATE SCREWS E2MMLE 21-Jul-2013 GAP PLATE SCREWS D31MLE 21-Jul-2013 GAP PLATE SCREWS D30MLE 21-Jul-2013 GAP PLATE SCREWS E2PMLE 21-Jul-2013 GAP PLATE SCREWS E2NMLE 21-Jul-2013 GAP PLATE SCREWS KM1MLE 23-Jul-2013 GAP PLATE SCREWS KM3MLE 23-Jul-2013 GAP PLATE SCREWS KM0MLE 25-Jul-2013 GAP PLATE SCREWS LH6MLE 25-Jul-2013 GAP PLATE SCREWS LH1MLE 25-Jul-2013 GAP PLATE SCREWS KM2MLE 25-Jul-2013 GAP PLATE SCREWS KM4MLE 25-Jul-2013 GAP PLATE SCREWS LH4MLE 25-Jul-2013 GAP PLATE SCREWS LEYMLE 28-Jul-2013 GAP PLATE SCREWS 7DTMNE 16-Sep-2013 GAP PLATE SCREWS 7DVMNE 16-Sep-2013 GAP PLATE SCREWS MERMH4 04-Dec-2013 GAP PLATE SCREWS MERMH7 04-Dec-2013 GAP PLATE SCREWS MERMH6 05-Dec-2013 GAP PLATE SCREWS MERMH5 08-Dec-2013 GAP PLATE SCREWS METHDN 21-Dec-2013 GAP PLATE SCREWS METHDT 21-Dec-2013 GAP PLATE SCREWS METHDP 28-Dec-2013 GAP PLATE SCREWS METKM8 30-Dec-2013 GAP PLATE SCREWS METKM7 30-Dec-2013 GAP PLATE SCREWS METHDR 06-Jan-2014

Orthopedic Devices

2

Yes

Worldwide Distribution

Stryker Orthopaedics Restoration Gap Plate Screw; || Dia. 6.5 mm, Lnth 15 mm; || Made in USA, Sterile; || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430.

Catalog number: 2080-0020; GAP PLATE SCREWS T0WMKE 01-Jul-2013 GAP PLATE SCREWS T0XMKE 02-Jul-2013 GAP PLATE SCREWS T10MKE 02-Jul-2013 GAP PLATE SCREWS T0YMKE 02-Jul-2013 GAP PLATE SCREWS 22RMLE 07-Jul-2013 GAP PLATE SCREWS 229MLE 07-Jul-2013 GAP PLATE SCREWS 22PMLE 08-Jul-2013 GAP PLATE SCREWS D01MLE 21-Jul-2013 GAP PLATE SCREWS AYYMLE 23-Jul-2013 GAP PLATE SCREWS PLAMME 27-Aug-2013 GAP PLATE SCREWS PN2MME 27-Aug-2013 GAP PLATE SCREWS PL8MME 28-Aug-2013 GAP PLATE SCREWS PL9MME 28-Aug-2013 GAP PLATE SCREWS PN1MME 28-Aug-2013 GAP PLATE SCREWS 7DXMNE 16-Sep-2013 GAP PLATE SCREWS MET9H4 18-Dec-2013 GAP PLATE SCREWS MET9X8 18-Dec-2013 GAP PLATE SCREWS MET9X7 22-Dec-2013 GAP PLATE SCREWS METL9Y 28-Dec-2013 GAP PLATE SCREWS METLA0 30-Dec-2013 GAP PLATE SCREWS MET9H5 30-Dec-2013 GAP PLATE SCREWS MET9X9 30-Dec-2013 GAP PLATE SCREWS MET9XA 30-Dec-2013 GAP PLATE SCREWS MHA4YT 14-Jan-2014 GAP PLATE SCREWS MHA4YR 18-Jan-2014 GAP PLATE SCREWS MHA55K 18-Jan-2014 GAP PLATE SCREWS MHA55L 18-Jan-2014 GAP PLATE SCREWS MHA55H 18-Jan-2014

Orthopedic Devices

2

Yes

Worldwide Distribution

Stryker Orthopaedics Restoration Gap Plate Screw; || Dia. 6.5 mm, Lnth 20 mm; || Made in USA, Sterile; || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430

Catalog number: 2080-0025; GAP PLATE SCREWS PTWMKE 27-Jun-2013 GAP PLATE SCREWS RY0MKE 30-Jun-2013 GAP PLATE SCREWS RXYMKE 02-Jul-2013 GAP PLATE SCREWS XE6MKE 07-Jul-2013 GAP PLATE SCREWS 22VMLE 07-Jul-2013 GAP PLATE SCREWS XE8MKE 09-Jul-2013 GAP PLATE SCREWS E1VMLE 20-Jul-2013 GAP PLATE SCREWS E1YMLE 20-Jul-2013 GAP PLATE SCREWS E1TMLE 23-Jul-2013 GAP PLATE SCREWS E1XMLE 23-Jul-2013 GAP PLATE SCREWS 5TTMNE 11-Sep-2013 GAP PLATE SCREWS 5TXMNE 11-Sep-2013 GAP PLATE SCREWS 5TWMNE 11-Sep-2013 GAP PLATE SCREWS 5TVMNE 16-Sep-2013 GAP PLATE SCREWS MERN1A 04-Dec-2013 GAP PLATE SCREWS MET03X 05-Dec-2013 GAP PLATE SCREWS MERN19 08-Dec-2013 GAP PLATE SCREWS MET03W 14-Dec-2013 GAP PLATE SCREWS METE8P 21-Dec-2013 GAP PLATE SCREWS METEVL 21-Dec-2013 GAP PLATE SCREWS METE8J 21-Dec-2013 GAP PLATE SCREWS METE8K 21-Dec-2013 GAP PLATE SCREWS METE8L 21-Dec-2013 GAP PLATE SCREWS METE8M 21-Dec-2013 GAP PLATE SCREWS METH2H 21-Dec-2013 GAP PLATE SCREWS METH2E 21-Dec-2013 GAP PLATE SCREWS METH2K 21-Dec-2013 GAP PLATE SCREWS METH2J 21-Dec-2013 GAP PLATE SCREWS METE8R 06-Jan-2014 GAP PLATE SCREWS METJ6V 06-Jan-2014 GAP PLATE SCREWS METJ6W 31-Dec-2013

Orthopedic Devices

2

Yes

Worldwide Distribution

Stryker Orthopaedics Restoration Gap Plate Screw; || Dia. 6.5 mm, Lnth 25 mm; || Made in USA, Sterile; || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430

Catalog number: 2080-0035; GAP PLATE SCREWS PTJMKE 29-Jun-2013 GAP PLATE SCREWS PTLMKE 29-Jun-2013 GAP PLATE SCREWS T0RMKE 06-Jul-2013 GAP PLATE SCREWS T0PMKE 06-Jul-2013 GAP PLATE SCREWS T0VMKE 06-Jul-2013 GAP PLATE SCREWS J47MLE 21-Jul-2013 GAP PLATE SCREWS J44MLE 21-Jul-2013 GAP PLATE SCREWS J45MLE 22-Jul-2013 GAP PLATE SCREWS J48MLE 22-Jul-2013 GAP PLATE SCREWS 4P9MNE 10-Sep-2013 GAP PLATE SCREWS 4PDMNE 11-Sep-2013 GAP PLATE SCREWS 4PAMNE 11-Sep-2013 GAP PLATE SCREWS 4P8MNE 11-Sep-2013 GAP PLATE SCREWS MERN4W 05-Dec-2013 GAP PLATE SCREWS MERN4X 05-Dec-2013 GAP PLATE SCREWS METD97 21-Dec-2013 GAP PLATE SCREWS METDE0 21-Dec-2013 GAP PLATE SCREWS METDDX 21-Dec-2013 GAP PLATE SCREWS METDE3 21-Dec-2013 GAP PLATE SCREWS METDE6 21-Dec-2013 GAP PLATE SCREWS METDE2 30-Dec-2013

Orthopedic Devices

2

Yes

Worldwide Distribution

Stryker Orthopaedics Restoration Gap Plate Screw; || Dia. 6.5 mm, Lnth 35 mm; || Made in USA, Sterile; || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430

Catalog number: 2080-0040; GAP PLATE SCREWS PTDMKE 27-Jun-2013 GAP PLATE SCREWS T0MMKE 01-Jul-2013 GAP PLATE SCREWS PT9MKE 02-Jul-2013 GAP PLATE SCREWS 34HMLE 09-Jul-2013 GAP PLATE SCREWS 34EMLE 14-Jul-2013 GAP PLATE SCREWS JKRMLE 23-Jul-2013 GAP PLATE SCREWS JKPMLE 23-Jul-2013 GAP PLATE SCREWS NL3MME 27-Aug-2013 GAP PLATE SCREWS NL6MME 27-Aug-2013 GAP PLATE SCREWS NL5MME 27-Aug-2013 GAP PLATE SCREWS NL4MME 28-Aug-2013 GAP PLATE SCREWS 7E4MNE 17-Sep-2013 GAP PLATE SCREWS 7E5MNE 17-Sep-2013 GAP PLATE SCREWS MERN50 05-Dec-2013 GAP PLATE SCREWS MERN4Y 05-Dec-2013 GAP PLATE SCREWS MET81P 18-Dec-2013 GAP PLATE SCREWS MET81T 18-Dec-2013 GAP PLATE SCREWS MET81V 18-Dec-2013 GAP PLATE SCREWS MET81R 22-Dec-2013 GAP PLATE SCREWS MET969 30-Dec-2013 GAP PLATE SCREWS MET967 30-Dec-2013 GAP PLATE SCREWS MET9H3 30-Dec-2013 GAP PLATE SCREWS MHA5LL 18-Jan-2014 GAP PLATE SCREWS MHA5LM 18-Jan-2014 GAP PLATE SCREWS MHA5LN 18-Jan-2014 GAP PLATE SCREWS MHA5LK 18-Jan-2014 GAP PLATE SCREWS MHA779 18-Jan-2014

Orthopedic Devices

2

Yes

Worldwide Distribution

Stryker Orthopaedics Restoration Gap Plate Screw; || Dia. 6.5 mm, Lnth 40 mm; || Made in USA, Sterile; || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430