Z-0270-2013Class II

AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd...

Name: Z-0270-2013 AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd...
Creator: Primus Medical LLC
Published: 2011-02-02
License: https://open.fda.gov/license/

Primus Medical LLC / initiated 2011-02-02 / Terminated / root cause: manufacturing process

FDA source

Primus Medical LLC began a recall of AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed on 2011-02-02. FDA classified it as Class II and gives the reason as "The "Retaining washers & Clevis Pins" provided with the AC -powered adjustable hospital beds may fail under certain circumstances. The pins at the top of the leg were disengaging from the channel. This may cause the bed...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0270-2013
Classification: Class II
Status: Terminated
Initiated: 2011-02-02
Posted: 2012-11-08
Terminated: 2014-05-14
Recalling firm: Primus Medical LLC
Product: AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall: The "Retaining washers & Clevis Pins" provided with the AC -powered adjustable hospital beds may fail under certain circumstances. The pins at the top of the leg were disengaging from the channel. This may cause the bed frame to come off tracks or collapse.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: The firm, Primus Medical LLC, sent an "Important Notification Relating to Primus Medical Product TL500" letter dated March 29, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to replace the "Retaining washers & Clevis Pins" with the "Clevis Pins & Bow Tie Cotter Pins" in the TL500-001 Service Pack provided with the letter in order to avoid any potential failure and/or bed collapse and to return the" Retaining washers & Clevis Pins" after the replacement procedure is performed. If you have any questions, or need assistance in performing the replacement, call 330-965-9681.
Quantity in commerce: 342 Beds
Distribution: Nationwide distribution: USA including states of: AZ, IL, KY, MD, MI, OH, OR, PA, TX and VA.
Product codes and lots: Model #TL500; Serial Number: 001, 002, 003, 004, 005, 006, 007, 010, 013, 014, 015, 016, 017, 018, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030, 031, 032, 033, 034, 035, 039, 040, 041, 042, 043, 044, 045, 046, 047, 048, 049, 050, 052, 053, 054, 055, 056, 057, 058, 059, 060, 061, 062, 063, 064, 065, 070, 075, 081, 09350014, 09350015, 09350016, 09350017, 09350018, 09350021, 09350023, 09350025, 09350026, 09350027, 09350028, 09350029, 09350030, 09350031, 09350032, 09350033, 09350035, 09350038, 09350040, 09350041, 09350042, 09350045, 09350048, 09350049, 09350054, 09350055, 09350056, 09350057, 09350058, 09350059, 09350060, 09350062, 09350063, 09350064, 09350065, 09350066, 09350067, 09350068, 09350069, 09350070, 09350072, 09350074, 09350082, 09350085, 09350087, 09350088, 09350089, 09350090, 09350091, 09350092, 09430001, 09430002, 09430003, 09430004, 09430005, 09430006, 09430007, 09430008, 09430010, 09430013, 09430014, 09430015, 09430017, 09430019, 09430020, 09430021, 09430022, 09430024, 09430026, 09430027, 09430028, 09430029, 09430030, 09430032, 09430033, 09430034, 09430036, 09430037, 09430038, 09430039, 09430040, 09430041, 09430042, 09430043, 09430044, 09430045, 09430046, 09430047, 09430049, 09430050, 09430051, 09430052, 09430053, 09430054, 09430056, 09430057, 09430058, 09430059, 09430060, 09430061, 09430062, 09430063, 09430065, 09430066, 09463067, 09430068, 09430069, 09430070, 09430071, 09430072, 09430074, 09430075, 09430076, 09430077, 09430078, 09430079, 09430080, 09430081, 09430083, 09430085, 09430086, 09430087, 09430088, 09430089, 09430091, 09430093, 09430094, 09430097, 09430099, 09430100, 09520001, 09520002, 09520003, 09520004, 09520005, 09520006, 09520007, 09520008, 09520009, 09520011, 09520012, 09520013, 09520015, 09520017, 09520018, 09520019, 09520020, 09520021, 09520022, 09520025, 09520026, 09520027, 09520028, 09520029, 09520030, 09520031, 09520032, 09520033, 09520034, 09520035, 09520036, 09520037, 09520038, 09520039, 09520040, 09520041, 09520042, 09520043, 09520044, 09520045, 09520046, 09520047, 09520048, 09520049, 09520050, 10040001, 10040003, 10040004, 10040005, 10040006, 10040007, 10040008, 10040009, 10040010, 10040011, 10040012, 10040013, 10040014, 10040015, 10040016, 10040017, 10040028, 10040029, 10040030, 10040032, 10040033, 10040034, 10040035, 10040036, 10040037, 10040038, 10040039, 10040040, 10040041, 10040042, 10040043, 10040044, 10040045, 10040046, 10040047, 10040048, 10040049, 10040050, 10040051, 10040052, 10040053, 10040054, 10040055, 10040056, 10040057, 10040058, 10040059, 10040062, 10040063, 10040064, 10040065, 10040066, 10040067, 10040068, 10040069, 10040070, 10040071, 10040073, 10040074, 10040075, 10040076, 10040077, 10040078, 10400029, 10400050, 10400056, 10400057, 10400058, 10400059, 10400065, 10370016, 10370017, 10370018, 10370019, 10370020, 10370032, 10370033, 10370034, 10370035, 10370038, 10370052, 10370053, 10370054, 10370056, 10370060, 10370063, 10370078, 10370079, 10370080 , 09380031, 09380029, 09380064, 09380070, 09380089, 09380040, 09380038, 09380085, 09380045, 09380054, 09380060, 09380059, 09380058, 09380048, 09380042, 09380038, 09380069, 09380063, 09380067 & 09380065.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0270-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0270-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-08

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)