Tap, Bone

FDA product code HWX · Class I (low risk) · 21 CFR 888.4540 · Orthopedic

2510(k) clearances
0PMA approvals
14recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K873067Acromed Bone Screw Tap SleevesHWX · Traditional Buckman Co., Inc.09/02/1987SE
K840735Femoral Cement Removal InstrumentHWX · Traditional Amtech Scientific, Inc.05/14/1984SE

Recalls

RecallProductFirmInitiated
Z-1703-2026 Class II2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot… Synthes (USA) Products LLC02/25/2026Open, Classified
Z-1702-2026 Class II2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot… Synthes (USA) Products LLC02/25/2026Open, Classified
Z-1453-2019 Class IICBS 7.5 tap, cannulated, AO, Item Number 503002041An investigation identified that the products were possibly manufactured from a different material than… Zimmer GmbH04/08/2019Terminated
Z-1637-2013 Class IITPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… Surgical Instrument Service And Savings, Inc.05/03/2013Terminated
Z-1718-2012 6.5 MM CANELLOUS TAP W/ QUICK CONNECT, REF 71173509, QTY: (1), STERILE R, Smith &…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… Smith & Nephew Inc04/13/2012Terminated
Z-0468-2011 CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error… Orthohelix Surgical Designs Inc10/15/2010Terminated
Z-0467-2011 CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error… Orthohelix Surgical Designs Inc10/15/2010Terminated
Z-0466-2011 CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error… Orthohelix Surgical Designs Inc10/15/2010Terminated
Z-1615-2010 8.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central…Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may… Blackstone Medical, Inc.04/21/2010Terminated
Z-1614-2010 7.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central…Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may… Blackstone Medical, Inc.04/21/2010Terminated
Z-1613-2010 6.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central…Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may… Blackstone Medical, Inc.04/21/2010Terminated
Z-1612-2010 5.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central…Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may… Blackstone Medical, Inc.04/21/2010Terminated
Z-1611-2010 4.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central…Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may… Blackstone Medical, Inc.04/21/2010Terminated
Z-0576-2009 Taps Model #'s: SYN311.15 SYN311.190 SYN311.39 and SYN311.32 An orthopedic manual…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… Sterilmed Inc08/08/2008Terminated